A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers
Phase: PHASE1
Conditions: Diabetes Type I, Diabetes Type II
Sponsor: Dr. Paul F. Gratzer

 
CONFIDENTIAL 
This protocol is the confidential information of DeCell Technologies, Inc., and is intended solely for the guidance of the clinical 
investigation. This protocol may not be disclosed to parties not associated with the clinical investigation or used for any purpose 
without the prior written consent of DeCell Technologies, Inc. 
 
CLINICAL STUDY PROTOCOL 
A Pilot Safety and Efficacy Study of DermGEN Dermal Regeneration  
Scaffold for the Treatment of Diabetic Foot Ulcers 
Test product: 
DermGEN  
Clinical study phase: 
 
Feasibility 
Sponsor: 
DeCell Technologies Inc. 
Sponsor’s scientific expert: 
Paul F. Gratzer, Ph.D., P.Eng. 
 
President and CEO 
 
Office: (902) 442-4668  
 
Cell: (902) 223-2179  
 
Fax: (902) 494-6621 
 
Email: pfgratzer@decelltechnologies.com 
 
www.decelltechnologies.com  
Sponsor’s clinical expert: 
Mark A. Glazebrook, MD FRCSC 
 
Orthopedic Surgeon 
 
Protocol number:  DCL-DFU11 
Version: 5.0      
Date: 28 March 2016 
 
 

Clinical Trial Protocol  
DermGEN™ DFU Study 11, v5.0 
 
Protocol Number DCL-DFU11 
 
Confidential 
Page 2 of 41 
 
STUDY IDENTIFICATION DATA 
 
 
 
Short Title 
DermGEN DFU Study 11 
Study Code 
DCL-DFU11 
Phase 
1 
Sponsor 
DeCell Technologies, Inc. 
Test Product 
DermGEN 
Dose/Route of 
Administration 
Topical 
CRO/Study Centre 
DeCell Technologies, Inc. 
Principal Investigator 
Mark Glazebrook, MD PhD FRCSC 
Version 
5.0 
Medical Monitor 
R. Eric McAllister, MD DPhil 
Date 
28 March 2016 

Clinical Trial Protocol  
DermGEN™ DFU Study 11, v5.0 
 
Protocol Number DCL-DFU11 
 
Confidential 
Page 3 of 41 
 
 
CONFIDENTIALITY STATEMENT 
 
This protocol contains information that is confidential and proprietary to DeCell Technologies, Inc. 
(“DeCell”) This information is being provided to you for the purpose of conducting a clinical study for 
DeCell. You may disclose the contents of this protocol to study personnel under your supervision who need 
to know the contents for this purpose, as well as to your Institutional Review Board(s) or Ethics 
Committee(s), subject to the following condition: The contents of this protocol may not be disclosed to any 
other person or entity without the prior written permission of DeCell, and may not be used for any purpose 
other than the conduct of this study. The foregoing shall not apply to disclosure required by governmental 
regulations or laws; however, you will give prompt notice to DeCell of any such disclosure. 
Any supplemental information that may be added to this document is also confidential and proprietary to 
DeCell and must be kept in confidence in the same manner as the contents of this protocol. 
Any person who receives this protocol without due authorization from DeCell is requested to return it to 
DeCell or to promptly destroy it. 
 
 
 

Clinical Trial Protocol  
DermGEN™ DFU Study 11, v5.0 
 
Protocol Number DCL-DFU11 
 
Confidential 
Page 4 of 41 
 
 
 
REVISION HISTORY 
 
 
 
 
 
Version 
Date 
By 
Description 
3.0 
24 Jun 2014 
P. F. Gratzer 
First circulated version, and with ethics approval.  No 
patients enrolled under this version at St. Michael’s 
Hospital.   
4.0 
08 Feb 2016 
R. E. McAllister 
Reformat without changes to protocol; circulated for 
comments.  
4.A 
08 Feb 2016 
R. E. McAllister 
Modify wording, no material changes to protocol 
4B 
09 Feb 2016 
R. E. McAllister 
Further modify wording, no material changes to 
protocol 
4C 
09 Feb 2016 
R. E. McAllister 
Alter methodology to promote study objectives more 
efficiently 
4D 
09 Feb 2016 
R. E. McAllister 
Incorporate comments and suggestions. 
5.0 
28 Mar 2016 
R. E. McAllister 
Revised circulated version.  This is the first version to 
be implemented at the St. Michael’s Hospital site.  
Changes from version 3.0 are:  
(a) Formatted to resemble ICH and FDA 
templates 
(b) One replacement application of DermGEN is 
permitted, if warranted. 
(c) Now provides for experience with up to 3 
patients excluded from the study analysis, 
before finalizing procedures. 
(d) Now specifically allows inclusion of patients 
with DFU healing after treatment of underlying 
osteomyelitis. 
(e) Allows for vacuum-assisted closure device 
over the wound. 
(f) Utilizes the SF-12 questionnaire in place of the 
SF-36, and LUMT document in place of 
MDLUC-AQ.  

Clinical Trial Protocol  
DermGEN™ DFU Study 11, v5.0 
 
Protocol Number DCL-DFU11 
 
Confidential 
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SPONSOR APPROVAL PAGE 
 
 
A Pilot Safety and Efficacy Study of DermGEN Dermal Regeneration Scaffold 
for the Treatment of Diabetic Foot Ulcers 
 
Version: 5.0 
Date: 28 March 2016 
 
Approved for DeCell Technologies, Inc. by: 
P.F Gratzer, PhD 
 
Date: 
 
 
 
 

Clinical Trial Protocol  
DermGEN™ DFU Study 11, v5.0 
 
Protocol Number DCL-DFU11 
 
Confidential 
Page 6 of 41 
INVESTIGATOR PROTOCOL AGREEMENT PAGE 
A Pilot Safety and Efficacy Study of DermGEN Dermal Regeneration Scaffold 
for the Treatment of Diabetic Foot Ulcers 
 
 I agree, as an Investigator conducting this study: 
 
To assume responsibility for the proper conduct of the study at this site. 
 
To conduct the study in compliance with this protocol, with any future amendments, and with any 
other written study conduct procedures provided and reviewed and approved by DeCell Technologies, 
Inc. (“DeCell”) 
 
Not to implement any significant deviations from or changes to the protocol without agreement from 
the sponsor and prior review and the written approval from the Institutional Review Board, except 
where necessary to eliminate an immediate hazard to the patients, or for administrative aspects of the 
study (where permitted by all applicable regulatory requirements). 
 
That I am thoroughly familiar with the appropriate use of the investigational product, as described in 
this protocol, and any other information provided by the sponsor including, but not limited to, the 
current Investigator’s Brochure or equivalent document provided by DeCell. 
 
That I am aware of, and will comply with, Good Clinical Practices (GCP) and all applicable 
regulatory requirements, including the regulations governing the use of controlled substances and 
devices. 
 
To ensure that all persons assisting me with the study are adequately informed about the 
investigational product, and that they are qualified to perform their study related duties and functions, 
as described in the protocol.  
 
That I have been informed that certain regulatory authorities require the sponsor to obtain and supply 
details about the Qualified Investigator's ownership interest in the sponsor or the study drug, and more 
generally about his/her financial ties with the sponsor. DeCell will obtain and disclose any relevant 
information in this regard solely for the purpose of complying with regulatory requirements.  Hence, 
I: 
– Agree to supply DeCell with all information regarding ownership interest and financial ties 
with that company (including those of my spouse and dependent children); 
– Agree to promptly update this information if any relevant changes occur during the course 
of the study and for one year following completion of the study; and 
– Agree that DeCell may disclose this information about such ownership interests and 
financial ties to regulatory authorities. 
 
Principal Investigator’s Name: 
 
(please print) 
 
 
 
 
Principal Investigator’s Signature 
 
Date 

Clinical Trial Protocol  
DermGEN™ DFU Study 11, v5.0 
 
Protocol Number DCL-DFU11 
 
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TABLE OF CONTENTS 
Clinical Study Protocol ................................................................................................................................. 1 
Study Identification Data .............................................................................................................................. 2 
Confidentiality Statement ............................................................................................................................ 3 
Revision History ............................................................................................................................................. 4 
Sponsor Approval Page ............................................................................................................................... 5 
Investigator Protocol Agreement Page .................................................................................................... 6 
Table of Contents ........................................................................................................................................... 7 
Acronyms & Abbreviations ....................................................................................................................... 10 
1. Study Background ............................................................................................................................... 11 
1.1 
Study Rationale ..................................................................................................................................... 11 
1.2 
Pre-clinical in vitro Data ........................................................................................................................ 13 
1.3 
Pre-Clinical in vivo Data ....................................................................................................................... 13 
1.4 
Safety Considerations .......................................................................................................................... 13 
1.4.1 
Harms ....................................................................................................................................................... 13 
1.4.2 
Benefits ..................................................................................................................................................... 13 
1.4.3 
Financial Compensation ........................................................................................................................... 13 
2. Study Objectives .................................................................................................................................. 13 
2.1 
Primary Objectives ............................................................................................................................... 14 
2.2 
Secondary Objectives .......................................................................................................................... 14 
3. Investigational Plan ............................................................................................................................. 14 
3.1 
Study Design ........................................................................................................................................ 14 
3.1.1 
Screening Procedures (Days -28 to -1) .................................................................................................... 14 
3.1.2 
Clinic Admission (Day 0)........................................................................................................................... 15 
3.1.3 
Subsequent Clinic Visits (Weeks 1, 2, 3, 4, 12, and 20)........................................................................... 15 
3.2 
Dose Selection and Use ...................................................................................................................... 15 
4. Study Population .................................................................................................................................. 16 
4.1 
General Considerations ....................................................................................................................... 16 
4.2 
Inclusion Criteria ................................................................................................................................... 16 
4.3 
Exclusion Criteria .................................................................................................................................. 16 
4.4 
Concomitant Medications .................................................................................................................... 17 
4.5 
Dietary and Other Restrictions ............................................................................................................ 18 
4.6 
Subject Completion and Withdrawal ................................................................................................... 18 
4.6.1 
Subject Completion .................................................................................................................................. 18 
4.6.2 
Subject Withdrawal ................................................................................................................................... 18 
5. Investigational Material Information ................................................................................................ 18 
5.1 
Investigational Material Identification ................................................................................................... 18 
5.2 
Packaging and Labelling ...................................................................................................................... 19 

Clinical Trial Protocol  
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5.3 
Handling and Storage .......................................................................................................................... 19 
5.3.1 
Receipt of Study Product by Clinical Site ................................................................................................. 19 
5.4 
Dispensing ............................................................................................................................................ 19 
5.5 
Accountability Procedures ................................................................................................................... 19 
5.6 
Method of Assigning Treatments ......................................................................................................... 19 
6. Study Procedures & Assessments .................................................................................................. 20 
6.1 
Study Procedures ................................................................................................................................. 20 
6.1.1 
Screening (Day −28 to −1) ....................................................................................................................... 20 
6.1.2 
Enrollment (Day 0) .................................................................................................................................... 20 
6.1.3 
Follow-up Procedures (Week 1 to Week 20) ............................................................................................ 20 
6.1.4 
Compliance ............................................................................................................................................... 21 
6.2 
Safety Assessments ............................................................................................................................. 21 
6.2.1 
Physical Examination ............................................................................................................................... 21 
6.2.2 
Adverse Events ........................................................................................................................................ 21 
6.2.3 
Clinical Laboratory Assessments.............................................................................................................. 21 
6.2.4 
Medication History .................................................................................................................................... 22 
6.2.5 
Concomitant Medications ......................................................................................................................... 22 
6.3 
Efficacy Assessments .......................................................................................................................... 22 
6.3.1 
Primary Outcome Measurements are the following: ................................................................................ 22 
6.3.1.1 
Wound Size .............................................................................................................................................. 22 
6.3.1.2 
Impact of Treatment.................................................................................................................................. 22 
6.3.2 
Secondary Outcome Measurements include the following: ..................................................................... 23 
7. Data Analysis and Statistical Considerations ............................................................................... 23 
7.1 
Statistical and Analytical Plans ............................................................................................................ 23 
7.1.1 
Analysis Populations ................................................................................................................................ 23 
7.1.2 
General Statistical Considerations ........................................................................................................... 23 
7.1.3 
Planned Analyses ..................................................................................................................................... 23 
7.1.3.1 
Analysis of Safety Assessments ............................................................................................................... 23 
7.1.3.2 
Analysis of Efficacy Assessments ............................................................................................................ 23 
7.1.3.3 
Demographics and Other Baseline Characteristics .................................................................................. 23 
7.2 
Determination of Sample Size ............................................................................................................. 24 
8. Study Administration ........................................................................................................................... 24 
8.1 
Data Collection and Database Construction ...................................................................................... 24 
8.2 
Regulatory and Ethical Considerations............................................................................................... 24 
8.2.1 
Ethical Conduct of the Study .................................................................................................................... 24 
8.2.2 
Notification to Primary Care Physician ..................................................................................................... 24 
8.2.3 
Regulatory Authority Approval .................................................................................................................. 25 
8.2.4 
Ethics Approval ......................................................................................................................................... 25 
8.2.5 
Subject Informed Consent ........................................................................................................................ 25 
8.2.6 
Principal Investigator Reporting Requirements ........................................................................................ 26 
8.3 
Privacy ................................................................................................................................................... 26 
8.3.1 
Subject Identifiers ..................................................................................................................................... 26 

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8.3.2 
Access and Disclosure of Personal Information ....................................................................................... 26 
8.3.3 
Release of Subject Information ................................................................................................................ 26 
8.3.4 
Consent for Collection, Access, Use and Disclosure of Subject Information ........................................... 27 
8.4 
Study Monitoring ................................................................................................................................... 27 
8.4.1 
Study Monitoring by Compliance Auditors ................................................................................................ 27 
8.4.2 
Study Monitoring by Sponsor ................................................................................................................... 27 
8.5 
Principal Investigator's Data Responsibility ........................................................................................ 27 
8.6 
Study and Site Closure ........................................................................................................................ 28 
8.7 
Subject Compensation and Indemnification ....................................................................................... 28 
8.8 
Publication Policy .................................................................................................................................. 28 
9. Adverse Events and Serious Adverse Events ............................................................................... 28 
9.1 
Definitions .............................................................................................................................................. 28 
9.1.1 
Adverse Events ........................................................................................................................................ 28 
9.1.2 
Serious Adverse Events and Serious Unexpected Adverse Events ......................................................... 28 
9.1.3 
Clinical Laboratory Abnormalities and Other Abnormal Assessments...................................................... 29 
9.2 
Evaluation of Adverse Events and Serious Adverse Events ............................................................. 29 
9.2.1 
Classification of Adverse Event Severity .................................................................................................. 29 
9.2.2 
Classification of Adverse Event Causality ................................................................................................ 30 
9.3 
Reporting Procedures .......................................................................................................................... 31 
9.3.1 
Contacting Sponsor Regarding Safety ..................................................................................................... 31 
9.3.2 
Reporting Period ....................................................................................................................................... 31 
9.3.3 
Any Adverse Event ................................................................................................................................... 31 
9.3.4 
Any Serious Adverse Event ...................................................................................................................... 31 
9.3.5 
Follow-Up of Adverse Events and Serious Adverse Events ..................................................................... 31 
9.4 
Insurance for Patients .......................................................................................................................... 32 
10. References ............................................................................................................................................. 33 
11. Appendices ............................................................................................................................................ 35 
APPENDIX 1:  DermGEN Characteristics .................................................................................................... 36 
APPENDIX 2: Health Canada’s Approval To Use DermGEN ..................................................................... 37 
APPENDIX 3: Informed Consent Document ................................................................................................ 38 
APPENDIX 4:  The Leg Ulcer Measurement Tool [LUMT] .......................................................................... 39 
APPENDIX 5: The SF-12 Health Survey ...................................................................................................... 41 
 

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ACRONYMS & ABBREVIATIONS 
AE 
Adverse Event  
ALP 
Alkaline Phosphatase 
ALT 
Alanine Aminotransferase 
AST 
Aspartate Aminotransferase 
BMI 
Body Mass Index 
BUN 
Blood Urea Nitrogen 
bpm 
Beats per minute 
CRF 
Case Report Form 
CNS 
Central Nervous System 
CV 
Cardiovascular 
ECG 
Electrocardiogram 
GCP 
Good Clinical Practice 
GGT 
Gamma-Glutamyl transpeptidase 
HbA1c 
Glycohaemoglobin 
HBsAg 
Hepatitis B Surface Antigen 
HCV 
Hepatitis C Virus 
HIV 
Human Immunodeficiency Virus 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board, or Ethics Review Committee, or similar entity 
i.v. 
Intravenous 
LDH 
Lactate Dehydrogenase 
LUMT 
Leg Ulcer Measurement Tool  
SAE 
Serious Adverse Event 

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1. 
STUDY BACKGROUND 
1.1 
Study Rationale 
The number of people afflicted by diabetes is increasing significantly every year worldwide, with an 
estimated 366 million affected in 2011 that is projected to reach 439 million by 2030 — approximately 10% 
of the world's adult population.  Of that population, up to 25% are expected to have chronic foot ulcers 
which can lead to significant complications: 85% of lower extremity amputations are an end result of 
diabetic ulcers2.  This equates to a limb being amputated somewhere in the world every 20 seconds due to 
diabetes3,4. In Canada, 9 million people are diabetic and between 1.35 and 2.25 million will suffer from 
chronic foot ulcers5. In Nova Scotia, which has one of the highest rates of diabetes in Canada, more than 
98,000 people are affected by diabetes, with between 14,700 and 24,500 people afflicted with chronic foot 
ulcers6,7. In addition, the problem of diabetes-related ulcers in Nova Scotia is projected to grow, with the 
number of people with diabetes increasing by at least 3% by 2020. 
The most common form and first line of treatment for chronic diabetic foot ulcers is the use of weekly 
debridement. Patients are assessed initially to determine which detriments to healing (infection, vascular 
insufficiency, uncontrolled diabetes, smoking, poor nutrition, deformity and poor offloading) of an ulcer 
may be present. These detriments are then treated for optimization over the ensuing weeks to months. 
During this time, patients will have local wound care with debridement and the wound will be cleaned of 
any infected and necrotic tissue, using sharp debridement until a pristine bleeding wound is obtained. The 
wound site is then wrapped with a non-adherent and moist dressing followed by dry gauze, and the site is 
protected from weight-bearing (i.e., is off-loaded). This procedure is repeated at set intervals until the 
wound either heals, or (once all detriments to healing have been optimized and the wound has not healed) 
treatment is determined to be futile. The success rate for complete wound closure with standard care is very 
low and variable, with a range from single digit percentage to as high as 50%, and if healing does occur, it 
takes on average 8 to 9.5 weeks8,9.  However, previous studies have shown that reduction in the area of the 
chronic wound during the first four weeks of treatment is a predictor of complete healing at 12 weeks10.  
Diabetic foot ulcers that persist more than 4 weeks have 5-fold higher risk of infection11.  Development of 
an infection in a foot ulcer increases the risk for hospitalization 55.7 times and the risk for amputation 155 
times11.  Any wound that remains unhealed after 4 weeks is cause for concern, as it is associated with worse 
outcomes, including amputations12.   
Costs associated with treating diabetic foot ulcers range by country and region, but in all cases are a major 
economic burden. For example, in the U.S. in 2007, $116 billion was directly spent on diabetes, with at 
least 33% of these costs linked to the treatment of diabetic foot ulcers with an average cost per ulcer episode 
of $13,179.  In Canada, the average cost of treating a diabetic foot ulcer is $10,736, with more than $150 
million in total spent annually5.   
Although standard of care is the most widely used treatment for diabetic foot ulcers and the main form of 
treatment in Canada, there are a number of advanced wound care products available to the clinician. Most 
products fall under the category of a biologic dressing ranging from cell-containing living skin analogs such 
as Apligraf® (Organogenesis) and Dermagraft® (Shire) to tissue-derived decellularized scaffolds like 
GraftJacket® decellularized human dermis (Wright Medical), Oasis® porcine small intestinal submucosa 
(Smith and Nephew), and EpiFix® dehydrated human amnionic membrane (MiMedix). These products are 
designed and promoted as wound healing and tissue regeneration matrices that, once applied to the patient, 
are integrated with and then resorbed by the patient’s body. The use of these treatments, however, has been 
limited due to their prohibitive cost and inconsistent clinical performance. For example, market leaders 
Apligraf®, Dermagraft®, and Graftjacket® range in price from $1,500-$2,500 USD for a 2” x 2” graft. 

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Protocol Number DCL-DFU11 
 
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Most importantly, although initial limited clinical studies used to prove effectiveness for marketing and 
reimbursement purposes were successful, performance of these products in general use has proven to be far 
less successful. The most expensive (and cell-based) products, Apligraf® and Dermagraft® are in fact not 
incorporated after application, and eventually are sloughed off the wound due to death of the cellular 
material within the graft. Further, even when successful, they have required from 6 to 10 reapplications of 
the product in order to achieve a wound closure rate of 35-55%14.  In the case of Dermagraft®, costs of 
manufacture, poor sales, and a recent failed clinical trial for venous ulcers prompted Shire to sell 
Dermagraft® assets to Organogenesis with a loss of $650 million USD15. In the case of the ultimate market 
leader in terms of sales, GraftJacket® decellularized human dermis (Wright Medical), inconsistent and low 
rates of healing have been attributed to the failure to adequately remove donor cell materials (DNA/RNA, 
HLA cell membrane proteins) while preserving the natural architecture of the remaining extracellular matrix 
(ECM) scaffold16,17. The presence of cell remnants and disruption of tissue architecture increases 
inflammatory reactions both in-vitro and in-vivo, leading to inadequate and incomplete healing18,19. It 
should be noted that only Dermagraft® has been approved for use in Canada, and treatment of most diabetic 
foot ulcer patients in Canada consists of debridement alone. 
In order to address this unmet need for a safe, consistent, and effective treatment for diabetic foot ulcers, a 
new start-up company located in Halifax, DeCell Technologies Inc. (“DeCell”), has developed its product 
DermGEN, a sterile, highly-purified, decellularized regeneration scaffold derived from donated human skin. 
This product and company have spun out of research conducted by Dr. Paul Gratzer (School of Biomedical 
Engineering, Dept. of Surgery) at Dalhousie University. Dr. Gratzer’s patent pending decellularization 
technology has been shown to be superior to others in achieving very high levels of cellular material 
removal (95-99%) including DNA/RNA, HLADR, HLA-ABC, and cytoskeletal proteins beta-actin and 
vimentin20.  In addition, the process maintains the natural composition and architecture of the ECM while 
creating a validated sterile product (See Appendix 1, Figures 1-5, Table 1). Using an immune-competent rat 
biocompatibility model (ASTM standard F1408 -97) and directly comparing DermGEN  to the leading 
competitor Graftjacket®, there was consistent superiority as DermGEN demonstrated lower inflammation, 
more-rapid vascularization, and better tissue remodeling at 1, 3 and 9 weeks post-surgery (See Appendix 1, 
Figures 6-14). It should be noted that a more rigorous model was used here with excellent results, as human 
tissue was implanted into a rat (that is, a xenograft). In practice, the human decellularized dermis will be 
used to treat human patients and therefore would be a much better situation with transplantation within the 
same species (i.e., an allograft). DeCell Technologies Inc. has already received approval from Health 
Canada to use DermGEN in humans (See Appendix 2). 
The purpose of this clinical trail is to perform a limited pilot study, the first study in man to assess the 
effectiveness and safety of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU), as a 
preliminary to studies in larger populations and different wound types. This will be a one-arm prospective 
study with control comparisons made to historical data for standard of care treatment of DFU’s 
(debridement, sterile moist bandages, off-loading of the foot) obtained within the Multi-Disciplinary Leg 
Ulcer Clinic (MDLUC) at the QEII Hospital. This study in Halifax will be mirrored in one other 
participating health care center in Toronto, with each center enrolling 5-10 patients for a total of 20 patients. 
Funding for this trial will be from a recently awarded (January 2014) CIHR Proof of Principle (POP) II 
Grant with Dr. Mark Glazebrook (Orthopaedic Surgeon, QEII Hospital) as Principal Investigator and Dr. 
Paul Gratzer (Associate Professor, Biomedical Engineering and CEO of DeCell Technologies Inc.) as the 
industrial sponsor. 
Since previous studies have shown that reduction in the area of the chronic wound during the first four 
weeks of treatment is a predictor of complete healing at 12 weeks10 and that DFU’s persisting more than 4 
weeks have 5-fold higher risk of infection11, we will be determining and comparing the reduction of wound 
size for our study at 1 and 4 weeks. Our primary outcome measures will be the proportion of patients with 

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Protocol Number DCL-DFU11 
 
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complete healing at 12 and 20 weeks. Time to complete healing, incidence of recurrence of ulcer, incidence 
of adverse events, wound characterization, and mean and median wound size will also be documented and 
compared over the 20-week scope of the study. 
Given the current standard of care for diabetic foot ulcers, DermGEN may be transformative to a new 
standard of care that will have a great impact on the lives and wellness of diabetic Canadians. The dramatic 
statistic of a limb being amputated somewhere in the world every 20 seconds due to diabetes is simply 
unacceptable. Having a cost-effective product like DermGEN available to clinicians could truly alter this 
appalling outcome. 
 
1.2 
Pre-clinical in vitro Data 
See Investigators’ Brochure. 
1.3 
Pre-Clinical in vivo Data 
See Investigators’ Brochure. 
1.4 
Safety Considerations 
DermGEN is expected to be a safe wound covering, with a favourable risk-benefit ratio as outlined below. 
1.4.1 Harms 
Possible complications with the use of DermGEN include maceration, specific or non-specific immune 
response, graft infection, graft resorption, or graft non-integration. Given the nature of the treatment and 
location and type of wound being treated, most adverse events may be stopped through the cessation of 
treatment with DermGEN.   
1.4.2 Benefits 
The possible benefits of the proposed study include a faster, more effective, and more cost effective 
resolution of a chronic diabetic foot ulcer.  
1.4.3 Financial Compensation 
Patients enrolling in this study receive no financial reward for participation.  The study treatment is 
provided at no cost. 
2. 
STUDY OBJECTIVES  
The purpose of this clinical trail is to perform a limited pilot study to indicate the safety and effectiveness of 
DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). 
Adverse events incidence is the only objective regarded as a safety issue.   

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2.1 
Primary Objectives 
Primary Outcome Measures: 
1. Mean and median reduction in wound area in the first 4 weeks.   
2. Proportion with complete healing in the first 12 weeks.  (Complete healing is defined as 100% 
epithelialization without drainage.) 
3. Incidence of adverse events. 
4. Impact of treatment, as measured by LUMT (Leg Ulcer Measurement Tool) and SF12 (See 
Investigational Plan, below)  
2.2 
Secondary Objectives 
Secondary Outcome Measures: 
1. Proportion with complete healing at any time point 
2. Time to first-measured complete healing  
3. Incidence of recurrence after complete healing 
4. Change in wound characteristics 
5. Mean and median reduction in wound area at 12 weeks 
3. 
INVESTIGATIONAL PLAN 
3.1 
Study Design 
This is an interventional, single-arm, prospective study of DermGEN applied to diabetic foot ulcers.  
The study treatment will be conducted for a total of up to 20 weeks, and 15-20 patients will be enrolled. 
In order for the treatment team to gain experience with the sizing and application of DermGEN and the 
most suitable off-loading methodology, the first one to three patients may have differing closure procedures, 
and will not be included in the per-protocol analysis of the study (although all safety data will be reported).  
Thereafter, the team will specify a single regimen of procedures, dressing types, and off-loading 
methodology to be used for all subsequent patients.   
3.1.1 Screening Procedures (Days -28 to -1) 
Potential subjects will be screened during the 4 weeks preceding Day 0 to determine if they meet the 
inclusion and exclusion criteria, and if all criteria are satisfied, will be eligible to participate in the clinical 
trial. All general and indication-specific entry criteria must be met before study entry. Subjects who enter 
the trial will be provided with an Ethics Committee approved written informed consent for review and 
signature (See Appendix 3). 
 

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3.1.2 Clinic Admission (Day 0) 
After enrollment and an initial assessment (time zero data), patients will be treated with DermGEN 
decellularized human dermal matrix. Following standard of care procedures, the wound will be debrided to 
provide healthy tissue margins and a bleeding wound bed. A 4 cm x 4 cm piece of DermGEN will be 
prepared by sizing to approximately 2-3 mm past the margins of the ulcer with the dermal side in contact 
with the wound bed, and securing it to the wound with sutures.  
A non-adherent dressing will be used to cover the DermGEN graft, followed by a moisture retentive 
dressing and either (a) a compressive dressing; or (b) a vacuum-assisted wound closure dressing (“VAC-
Assist”).  All patients will have the same brands and types of dressings applied, except for the first 1 to 3 
patients treated (see final paragraph, section 3.1 above).   
 
3.1.3 Subsequent Clinic Visits (Weeks 1, 2, 3, 4, 12, and 20) 
Follow up visits will be at 1, 2, 3, 4, and 12 and 20 weeks and as required for clinical care of active 
detriments to healing and local wound care.  
The LUMT will be administered at each of the 1, 2, 3, 4, and 12 and 20 weeks FU visits in order to capture 
data relevant to the study. The SF-12 survey will be administered at time 0, 4, 12 and 20 weeks post-
treatment. 
Digital photography will be utilized to capture the appearance and size of the ulcer at each visit.  Clinic 
photographs will be taken with the digital camera supplied by DeCell.  Other photographs to demonstrate 
the condition of the wound between clinic visits may be taken with any digital camera (including 
smartphones), and a measuring ruler must be visible in each picture.  Patients and caregivers are to be 
encouraged to take their own photographs if the wound ever becomes uncovered or visibly stained – again 
ensuring that some ruler appears in the photos – and copies should be provided to the study staff.   
Dressing changes will occur at each visit, and a record of these changes kept. All patients will receive 
appropriate wound off-loading using a device appropriate to ulcer location.  All post-treatment 
complications will be recorded on the appropriate case report form. 
Patients with complications that may be managed by further treatment, for example antibiotic 
administration or reapplication of another DermGEN graft, will remain in the study.   
For any subject who requests study withdrawal or is withdrawn by the investigator, the reason for study 
discontinuance will be recorded by the Principal Investigator on the appropriate case report form.  
 
3.2 
Dose Selection and Use 
DermGEN will be applied on Day 0, following the directions for use. 
If at a subsequent visit the product material is deteriorating, then the investigator may, at his discretion, 
remove the remaining product material, prepare the wound bed appropriately, and apply one new DermGEN 
treatment.  In such cases, the remaining course of the study will continue unchanged, and the patient’s last 
visit will still be at Week 20.   

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The reasons for any second application of DermGEN must be carefully documented, together with before 
and after photographs showing the deteriorating specimen in situ before removal and also the new specimen 
in place prior to applying new dressings.   
4. 
STUDY POPULATION 
4.1 
General Considerations 
A total of 15-20 patients will be enrolled for the study, with patients enrolled in each of the following 
participating centers: Halifax and Toronto.   
Ages will include 18 and older from both sexes. Potential subjects will be screened to determine if they 
meet the inclusion and exclusion criteria and if all entry criteria are achieved, will be eligible to participate 
in the clinical trial. All general and indication-specific entry criteria must be met before study entry. 
Subjects who enter the trial will be provided with an Ethics Committee approved written informed consent 
for review and signature. 
4.2 
Inclusion Criteria 
A subject will be considered eligible to participate in this study if each of the following inclusion criteria is 
satisfied: 
1. Patient with documented stable Type I or II diabetes (HbA1C >7.0 within 1 month prior to Day 0). 
2. Patient’s ulcer has been present for a minimum of 2 weeks as of Day 0. 
3. Study ulcer has healed <30% in size during the 2 weeks prior to Day 0. 
4. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study. 
5. Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, 
tendon, bone or joint capsule. 
6. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue 
suitable for skin grafting on Day 0.  
7. Patient has adequate circulation to the foot as evidenced by palpable pulse or pulse detectable 
with Doppler ultrasound, and lack of visible cyanosis in skin bordering the ulcer.  
8. Female patients are not pregnant at time of, or during study. 
9. Patient and caregiver ready and willing to participate and comply with follow-up regime. 
10. Patient or legal representative has read and signed the Institutional Ethics Review Board approved 
informed consent form. 
 
4.3 
Exclusion Criteria 
A subject will not be considered eligible to participate in this study if any one of the following exclusion 
criteria is satisfied: 
1. Evidence of gangrene on affected foot. 

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2. Ulcer is over Charcot deformity (fractures or dislocation). 
3. Ulcer is non-diabetic in etiology. 
4. Ulcer has tunnels or sinus tracts that cannot be completely debrided. 
5. Medical condition(s) that in the Investigator’s opinion make the patient inappropriate for study 
6. Patient has/had malignant disease not in remission for 5 years or more 
7. Patient has acute or chronic hepatitis, cirrhosis, serum albumin <2.0 gm/dL, or has alkaline 
phosphatase or LDH at twice the normal upper limit 
8. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is 
anticipated to require such agents during study 
9. Patient received radiation therapy within 30 days of Day 0 of study 
10. Patient has AIDS or is infected with HIV 
11. Patient has participated in another study using investigational drug(s) or device within the previous 30 
days 
12. Obvious clinical signs and symptoms of ongoing cellulitis or osteomyelitis 
13. Patient has any other condition which seriously compromises their ability to complete the study 
14. Patient has known allergies to antibiotics, such as penicillin and streptomycin 
15. Patient has a history of bleeding disorder 
16. Patient received elective osseous procedures to the study foot within 30 days prior to screening visit, 
except that patients whose DFU overlies an area of treated osteomyelitis may be included, providing 
there exists a suitable base for application of the DermGEN. 
 
4.4 
Concomitant Medications 
In general, there is no reason to expect medications to interact with DermGEN.  Only medications 
considered prejudicial to wound healing are prohibited.  These include, but are not necessarily restricted to, 
the following: 
 
Corticosteroids, either topical near the ulcer, or systemic 
 
Immunosuppressive drugs of any type, either topical near the ulcer, or systemic 
 
Anti-infective agents used topically, if believed to be cytotoxic 
Patients will remain on all medications prescribed to treat their diabetes and associated conditions as 
determined at the point of enrolment. If there are any changes to a patient’s medication (dosing, new 
medications, alternate medications) during the study, this will be noted in the patient’s study file and 
reviewed by the study supervising clinician to determine continued eligibility of the patient in the study. 
Patients with complications that may be managed by further treatment, for example antibiotic 
administration or reapplication of another DermGEN graft, will remain in the study.   

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4.5 
Dietary and Other Restrictions 
None.  A prudent diet for control of diabetes is encouraged.   
4.6 
Subject Completion and Withdrawal 
4.6.1 
Subject Completion 
Patients will be required to attend all scheduled appointments specified for the study. If required, 
appointments may be re-scheduled within a week of the original appointment date. Patients will be required 
to adhere to home care regimes as provided verbally and in writing by their clinician, including dressing 
changes, off-loading of the affected limb, and immediate reporting of adverse events such as infection, 
continued bleeding, excessive inflammation and pain.   
4.6.2 
Subject Withdrawal 
Any subject who voluntarily withdraws (e.g., withdrawal of consent) or is discontinued (e.g., as a result of 
an AE) from the study prior to the completion of all assessments will be considered as having withdrawn 
from the study.  
Subjects may be withdrawn from the study under any of the following circumstances: 
 
(i) patient is non-compliant with home care regime (e.g. not wearing off-loading cast),  
 
(ii) presence of recurrent, untreatable infection,  
 
(iii) patient develops illness after enrollment that may unduly affect ulcer healing,  
 
(iv) patient requires more than one re-treatment with DermGEN 
When an event such as a family emergency, a transient intercurrent illness (such as a cold) unrelated to 
study medication, or a remediable act of non-compliance prevents a subject from participating in a 
scheduled visit but the subject wishes to continue in the study, then with the agreement of the investigator, 
the clinical staff may attempt to reschedule the visit and retain the subject in the study.  
If a subject is prematurely discontinued from participation in the study for any reason after treatment has 
begun, the investigator or designee must make every effort to perform the assessments scheduled for the 
Follow-Up Visit (section 6.5.1). The reason for withdrawal will be recorded in the CRF and the subject’s 
medical record. 
5. 
INVESTIGATIONAL MATERIAL INFORMATION 
5.1 
Investigational Material Identification 
Donor human skin received from certified tissue banks will have a unique identifier assigned by the tissue 
bank. After decellularization processing by DeCell Technologies Inc., each piece of decellularized skin will 
be given a unique product code assigned by DeCell that will allow tracing to donor tissue received from 
tissue banks.  

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5.2 
Packaging and Labelling 
DermGEN will be provided in a hydrated form stored at room temperature. It will be supplied within a 
sterile, sealed specimen container containing phosphate buffered saline solution containing 
streptomycin/penicillin.  
DermGEN will be labelled with a product code that will identify it with a specific date of manufacture and 
tissue source. The product name, DeCell Technologies Inc. logo, and date of manufacture will also appear 
on the label separately as well as the following text: “Store at room temperature. Do not re-sterilize. Do not 
freeze. Do not re-seal. Not for sale, for sanctioned clinical trial only. Use aseptic technique to open 
packaging and handle product inside.”  
5.3 
Handling and Storage 
Shipping in the container provided requires no special handling procedures.   
As prescribed on the package label, the product should be stored at room temperature. It should not be re-
sterilized, re-frozen, or re-sealed. If not used within 4 hours, it should be discarded according to locally-
approved procedures.  It is not for sale, and is for sanctioned clinical trial use only.  
Use aseptic technique to open packaging and handle product inside. 
5.3.1 
Receipt of Study Product by Clinical Site 
Upon receipt by the study site, the clinical site staff will examine the shipment to verify it has been received 
in acceptable condition.  
5.4 
Dispensing 
The study product will be dispensed and administered according to study specific procedures. Only subjects 
participating in the study will receive it. Only authorized clinical staff may supply or administer it. 
5.5 
Accountability Procedures 
Clinic records will be maintained to capture the following information: 
a) Quantity received, 
b) The current quantity on site, 
c) Quantity used on each subject, 
d) Quantity removed from stock but not dispensed (e.g., damaged, dropped, spilled), and 
e) Quantity remaining at the end of the study and retained, returned, or destroyed, as per the sponsor’s 
instructions. 
5.6 
Method of Assigning Treatments 
All patients enrolled in the study will receive similar treatment.  There is no blinding of treatment 
assignments.   

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6. 
STUDY PROCEDURES & ASSESSMENTS 
6.1 
Study Procedures  
6.1.1 Screening (Day −28 to −1)  
Patients may be enrolled in the study at or any time after initial presentation if it can be documented that 
they comply with all inclusion and exclusion criteria.  (Enrollment day is designated as Day 0.)  The 
investigator or designee will discuss with each subject the nature of the study, its requirements, and its 
restrictions. Written informed consent will be obtained prior to the performance of any protocol-specific 
procedures  
The following will be required during the Screening period to determine eligibility: 
 
Informed consent 
 
Subject demographics 
 
Medical history 
 
Review of concomitant medication 
 
Relevant physical examination  
 
Vital signs  
 
Clinical laboratory tests 
 
Hepatitis B, Hepatitis C, and HIV screening 
 
Review of inclusion and exclusion criteria and study restrictions 
6.1.2 Enrollment (Day 0) 
After enrollment and an initial assessment including the Leg Ulcer Measurement Tool [LUMT] (see 
Appendix 4), patients will be treated with DermGEN decellularized human dermal matrix. Following 
standard of care procedures, the wound will be debrided to provide healthy tissue margins and a bleeding 
wound bed. A 4 cm x 4 cm piece of DermGEN will be prepared by sizing to approximately 2-3 mm past the 
margins of the ulcer and securing to the wound with sutures ensuring that the dermal side is in contact with 
the wound bed. [The dermal side of DermGEN can be identified by the following: (i) apply a drop of blood 
or contact with blood from the wound bed to one surface of the graft; (ii) rinse blood off with sterile saline; 
(iii) if blood does not wash off entirely, this is the dermal side—the epidermal side will not retain visible 
quantities of blood.]  A non-adherent dressing will be used to cover the DermGEN graft, followed by (a) a 
moisture retentive dressing and a compressive dressing, or (b) dressings as specified for use by all patients, 
once the first 1 to 3 patients have been treated (see section 3.1, above).  Suitable off-loading will also be 
provided, with careful instructions for use.   
6.1.3 Follow-up Procedures (Week 1 to Week 20) 
Follow up visits will be at Weeks 1, 2, 3, 4, and 12 and 20, and as required for clinical care of active 
detriments to healing and local wound care. The Leg Ulcer Measurement Tool [LUMT] will be completed 
at each of the Weeks 1, 2, 3, 4, 12, & 20 follow-up visits in order to capture data relevant to the study. In 
addition, digital photography will be utilized to capture the appearance and size of the ulcer at each visit. 
The SF-12 survey will be administered at Day 0, and at the Weeks 4, 12 and 20 visits. 

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Dressing management will follow and a record of all changes will be kept. All patients will receive wound 
off-loading using a device appropriate to ulcer location.  
All post-treatment complications will be recorded on the appropriate case report form. Patients with 
complications that may be managed by further treatment, for example antibiotic administration or 
application of one replacement DermGEN graft, will remain in the study.  
For any subject who requests study withdrawal or is withdrawn by the investigator, the reason for study 
discontinuance will be recorded by the Principal Investigator on the appropriate case report form. Stopping 
treatment or withdrawal from the study will occur when: 
 
(i) patient is non-compliant with home care regime (e.g. not wearing off-loading cast),  
 
(ii) presence of recurrent, untreatable infection,  
 
(iii) patient develops illness after enrollment that may unduly affect ulcer healing,  
 
(iv) patient requires more than one re-treatment with DermGEN 
6.1.4 
Compliance 
Patients will be required to attend all scheduled appointments required for the study. If required, 
appointments may be re-scheduled within a week of the original appointment date. Patients will be required 
to adhere to home care regimes as provided verbally and in writing by their clinician including dressing 
changes, off-loading of the affected limb, and immediate reporting of adverse events such as infection, 
continued bleeding, excessive inflammation and pain.  Patients will be encouraged to take their own 
photographs of any untoward signs.   
6.2 
 Safety Assessments 
6.2.1 
Physical Examination 
A relevant physical examination assessing the subject’s overall health and physical condition will be will be 
performed at every visit. 
6.2.2 
Adverse Events 
All AEs occurring after the subject has signed the ICF until the end of the Follow-up period will be 
recorded. AEs present at first dosing or any AE identified prior to first dosing will be recorded in the source 
documentation as Baseline Signs and Symptoms.  
AEs will be ascertained on the basis of volunteered signs or symptoms and on clinical observation and 
assessment at study visits. Spontaneous AEs will be recorded as such, and AEs will also be elicited by 
clinical site staff using non-leading questions at designated time points.  
All SAEs will be followed until resolved or until a stable status has been achieved. 
6.2.3 
Clinical Laboratory Assessments 
Patients must have recent HbA1c data in order to qualify for enrollment, and be not excluded on other health 
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Other laboratory data obtained during the study as part of usual care should be available for audit by the 
sponsor during the study and for 6 months after; but no specific testing is required by this protocol.    
Laboratory safety data will be reviewed by the investigator or designee as part of usual care. 
6.2.4 
Medication History 
All medications (prescription and non-prescription, herbal medications, or investigational drugs) taken by 
the subjects during the 14 days prior to Screening and during the remainder of the study will be recorded in 
the source documentation. The reported medications will be reviewed and evaluated by the investigator or 
designee to determine if they affect the subject’s eligibility to participate in the study. 
6.2.5 
Concomitant Medications 
Patients will remain on all medications prescribed to treat their diabetes and associated conditions as 
determined at the time of enrolment. If there are any changes to a patient’s medication (dosing, new 
medications, alternate medications) during the study, this will be noted in the patient’s study file and 
reviewed by the study supervising clinician to determine continued eligibility of the patient in the study.  
6.3 
Efficacy Assessments 
6.3.1 Primary Outcome Measurements are the following: 
1. Mean and median reduction in wound area in the first 4 weeks  
2. Proportion with complete healing in the first 12 weeks.  (Complete healing is defined as 100% 
epithelialization without drainage.) 
3. Incidence of adverse events  
4. Impact of treatment, as measured by LUMT and SF-12. 
6.3.1.1 
Wound Size 
Wound size will be assessed: 
a) By direct measurement of largest and smallest dimensions; and  
b) By estimation from a photograph with a measurement scale shown beside the wound.  Photographs 
should be taken from a distance of approximately 6 inches, and from vertically above the centre of 
the ulcer. 
6.3.1.2 
Impact of Treatment 
The impact of treatment will be analyzed using the LUMT and the Short-Form Health Survey (SF-12), both 
reliable and validated outcome measures.  
The Leg Ulcer Measurement Tool (LUMT) provides numerical scale grading of clinician- and patient-rated 
domains (see Appendix 4). 
The short form health survey (SF-12) is a 12-question assessment of mental and physical health and quality 
of life outcomes.  (See Appendix 5)  

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6.3.2 Secondary Outcome Measurements include the following: 
1. Time to complete healing 
2. Time to first-measured complete healing  
3. Incidence of recurrence after complete healing 
4. Change in wound characteristics over time 
5. Mean and median reduction in wound area at 12 weeks 
 
7. 
DATA ANALYSIS AND STATISTICAL CONSIDERATIONS 
7.1 
Statistical and Analytical Plans 
7.1.1 
Analysis Populations 
Safety population: all subjects will be included in the analysis for safety. 
Efficacy population: all subjects excepting the first 1 to 3 (i.e. those treated before standardization of 
procedures) will be included in the analysis to seek efficacy signals. 
7.1.2 
General Statistical Considerations 
This small study is not expected to support statistical conclusions.  Descriptive statistics will be used 
throughout.   
7.1.3 
Planned Analyses 
7.1.3.1 
Analysis of Safety Assessments 
Safety data include treatment-emergent AEs, physical exams, and clinical laboratory assessments. 
Narrative summary reports will constitute the adverse event database, with simple summary analysis.  
Systemic effects are not expected due to DermGEN alone, and such AE’s may be expected to be caused by 
the underlying ulcer.  All serious AE’s will be reported as required by GCP, and will be described in full in 
the final study report.  
7.1.3.2 
Analysis of Efficacy Assessments 
Photographic, narrative, and laboratory data will be examined in various ways to seek a signal of efficacy.  
Conclusions may be used to design more rigorous efficacy investigations in one or more subsequent studies.   
7.1.3.3 
Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics will include age, ethnic origin, height, weight, and BMI. Other 
baseline information will include relevant medical and surgical history, and prior and concomitant 
medications. Descriptive statistics (number of subjects, mean, standard deviation, median, minimum and 
maximum) for continuous variables, and the proportion of subjects for categorical variables will be 

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presented for demographic and baseline characteristics using the safety population. No formal statistical 
comparison between the groups will be performed. 
All important deviations related to study inclusion or exclusion criteria, conduct of the trial, subject 
management, or subject assessment will be described. Relevant medical and surgical history will be listed.  
7.2 
Determination of Sample Size 
The sample size chosen for this study was based upon precedent set by other first in human studies of 
similar nature and was not based on power calculations. 
8. 
STUDY ADMINISTRATION 
8.1 
Data Collection and Database Construction 
For all data collected on the CRF, source documentation should be available at the site. A source document 
checklist will be used to identify the source data for all data points collected. 
For the clinical trial, DeCell Technologies will assign a unique identifier for each patient enrolled in the 
study and this identifier will be used on all Case Report Forms (CRFs) and any other documents sent to 
DeCell throughout the study. Information collected under the unique identifier for each patient will be 
devoid of any specific personal information that may directly identify an individual. Only each clinician’s 
study coordinator and the clinicians themselves participating in the study will know the identity of their 
patients and their assigned unique study identifier for traceability. DeCell Technologies will know the 
unique patient identifier and unique product code of decellularized skin used to treat the patient for 
traceability. Data for the study will be captured on a paper version of CRFs and sent to DeCell Technologies 
who will enter all the data into an electronic database created in Microsoft Excel© that will be encrypted 
with a password. Access to the database will only be made available to the Halifax-based Study 
Coordinator, the P.I. of each participating site, and DeCell Technologies Inc.   
8.2 
Regulatory and Ethical Considerations 
8.2.1 
Ethical Conduct of the Study 
This study will be conducted in accordance with GCP and all applicable regulations, including, where 
applicable, the Declaration of Helsinki. The study will also be carried out in keeping with applicable local 
laws and regulations. This may include an inspection by the sponsor representatives and/or regulatory 
authority representatives at any time. 
8.2.2 
Notification to Primary Care Physician 
If agreed to by the subject, the investigator or designee will notify the subject’s primary care physician of 
the subject’s participation in the study. The primary care physician may contact the investigator for any 
further information regarding the subject’s participation in the study. 

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8.2.3 
Regulatory Authority Approval 
In accordance with any applicable local regulations, the sponsor or designee will obtain approval from the 
appropriate regulatory agency prior to a site initiating the study in that country or jurisdiction. 
8.2.4 
Ethics Approval 
It is the investigator’s responsibility to ensure that this protocol is reviewed and approved by the appropriate 
Ethical Review Committee or Institutional Review Board (IRB). 
The IRB must also review and approve the site’s ICF and any other written information provided to the 
subject, prior to the enrollment of subjects; and any advertisement that will be used for subject recruitment. 
The investigator or designee must forward to the sponsor copies of the IRB approval and the approved 
informed consent materials, which the sponsor must receive prior to the start of the study. 
If during the study, it is necessary to amend study documentation (e.g., protocol, ICF, etc.), the investigator 
or designee will be responsible for ensuring that the IRB reviews and approves these amended documents. 
IRB approval of the amended ICF must be obtained before new subjects consent to take part in the study, 
using this version of the form. Copies of the IRB approval of the amended ICF and the approved amended 
ICF must be forwarded to the sponsor as soon as available. 
8.2.5 
Subject Informed Consent 
All relevant study information will be summarized in an informed consent form (completed in collaboration 
with the sites) provided by DeCell. The investigator or designee will explain all relevant aspects of the 
study to the patients prior to entry unto the study (i.e., before any examinations and procedures 
associated with the selection for the study are performed or any study-specific data is records on study-
specific forms). 
The patient will have ample time and opportunity to ask questions and will be informed about the right to 
withdraw from the study at any time without any disadvantage and without having to provide reasons for 
their decision. 
Then the patient and investigator or designee will sign and date the form. The patient will receive a 
copy of the signed and dated form. 
The signed informed consent form will remain in the investigator site file, or if locally required in the 
patient’s note/file of the medical institution. If informed consent is obtained on the date the study specific 
procedures are performed, the study record or the patient’s clinical record must clearly show that 
information consent was obtained prior to these procedures. 
The informed consent form and any other written information provided to the patient will be revised 
whenever important new information becomes available that may be relevant to the consent, or if there is 
an amendment to the protocol that necessitates a change to the content of the written informed consent 
form. The investigator will inform the patient of the changes in a timely manner and will ask the patient 
to confirm participation in the study by signing the revised informed consent form. Revised informed 
consent forms must receive the IRB’s approval before implementation. 
Patient information (both locally and from participating sites) will be identified by a study number. 
Patient identifiers (name, health card number, and hospital specific identifying numbers) will not be 
included in study records. Patients will be coded by a number indicating the site and chronological 
number of enrollment at that site. 

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8.2.6 
Principal Investigator Reporting Requirements 
In accordance with applicable local regulatory requirements, the investigator may be obligated to provide 
periodic safety updates on the conduct of the study at his or her clinical site and notification of study closure 
to the IRB. Such periodic safety updates and notifications are the responsibility of the investigator and not 
of the sponsor. 
8.3 
Privacy 
All records identifying the patient will be kept confidential and to the extent permitted by the applicable 
laws and/or regulations, will not be made publicly available. 
Patient names will not be supplied to DeCell. Only the patient’s study number will be recorded in the CRF. 
If the patient’s name appears on any other document, it will be anonymized. Study data stored in a computer 
will be handled in accordance with local data protection laws. As part of the informed consent process, the 
patients will be informed in writing that representatives of DeCell, the IRB, or regulatory authorities may 
inspect their medical records to verify collected information and that all personal information made 
available for inspection will be handled in strictest confidence and in accordance with local data and health 
information protection laws. If the results are published, the patient’s identity will remain confidential. The 
principal investigator at each site will maintain a list to enable patients to be identified. 
8.3.1 
Subject Identifiers 
De-identified study data will be collected via paper CRF and transferred to DeCell. Subjects will be 
assigned a study number and this will be used for documentation throughout the clinical trial. This number 
and the patient’s initials are the only identification that will be used on data collection forms. Study records, 
paper and electronic, will be kept in a secure location at the clinical site and/or hospital record department.  
8.3.2 
Access and Disclosure of Personal Information 
Study data will be entered into a secured electronic database stored at DeCell Technologies’ main office on 
a password protected computer, with separate password required to access the database. The database will 
be backed-up with encryption to an external local and off-site hard-drive. Only study staff and DeCell will 
have access to this data. The electronic database will track subjects by an assigned 5-digit number and 
subject initials. No identifying information is entered into the database system. The subject’s assigned 5-
digit number will be the only identifier used on all correspondence to DeCell. 
The following personnel will have access to the personal information: members of the IRB of record, the 
study staff at each site as outlined in the delegation log, and quality assurance staff and auditors. 
 
8.3.3 
Release of Subject Information 
The results of this study will be reported in such a manner that subjects will not be identifiable in any way. 
Published reports or presentations will refer to grouped data or coded individual data and not to any 
identifiable individuals. Study reports sent to the sponsor or regulatory agencies will not include subject 
names. 

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8.3.4 
Consent for Collection, Access, Use and Disclosure of Subject Information 
By signing the ICF, the subject consents to the collection, access, use, and disclosure of his or her 
information as described in that document. If a subject withdraws consent, some of the subject’s 
information may still be collected, used, and disclosed by those involved in this study per applicable laws. 
8.4 
Study Monitoring 
8.4.1 Study Monitoring by Compliance Auditors 
All study data will be reviewed by the Scientific Advisory Board (SAB) of DeCell Technologies Inc. 
DeCell may conduct an audit to ensure compliance with GCP and regulatory authorities. The 
investigator/institution will be informed of the audit outcome. In addition, inspections by regulatory health 
authority representatives, funding agency, or ethics review board might occur and the site will notify DeCell 
immediately. 
The investigator/institution agrees to allow the auditor or inspector direct access to all the relevant 
documents and allocate time to the auditor/inspector to discuss any findings. 
 
8.4.2 Study Monitoring by Sponsor 
In accordance with GCP, DeCell’s representatives will review the protocol, study requirements and 
responsibilities with the site staff including identification or source data items. DeCell will monitor the site 
to verify that data are authentic, accurate, complete and that the safety and rights of participating patients 
are being protected. In addition, it will assess if the study is conducted in accordance with the latest version 
of the protocol and study agreements. The investigator and representative of the institution (where 
applicable) agree to allow the monitor direct access to all relevant documents. 
 
8.5 
Principal Investigator's Data Responsibility 
The principal investigator of each site must sign the protocol signature sheet before recruitment may start at 
the respective center. Likewise, all protocol amendments/integrated protocols must be signed and dated by 
the principal investigator before coming into effect at their respective center. A complete list of all 
participating centers and their investigator as well as all required signature documents, will be maintained in 
DeCell’s study file. 
The investigators and key personnel will be listed in the study file. 
All other study personnel are identified in a separate personnel list (not part of this clinical study protocol) 
as appropriate. This list will be updated as needed; an abbreviated version with personnel relevant for the 
centers will be available in each center’s investigator site file. 
Whenever the term “the investigator” is noted in the protocol text, it may refer to either the principal 
investigator at the site or an appropriately qualified, trained and delegated individual of the investigational 
site. 

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8.6 
Study and Site Closure 
This study may be terminated early if adverse events directly related to the use of DermGEN are observed 
within a significant number of patients. 
 
8.7 
Subject Compensation and Indemnification 
Subjects will not be compensated for participation in the study.  
8.8 
Publication Policy 
DeCell is committed to the results of every study it performs. DeCell in collaboration with the participating 
investigators will be responsible for publication and presentation strategy. All publications will follow 
institutional and tri-council policies and will be based on data released and agreed to by DeCell. The 
synopsis of the study protocol has been made available on the Internet at www.clinicaltrials.gov.   
 
9. 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
All post -treatment complications and adverse events will be recorded on the appropriate case report form. 
This study may be terminated early if adverse events directly related to the use of DermGEN are observed 
within a significant number of patients. 
The investigator or designee and clinical site staff are responsible for the detection, documentation, and 
reporting of events meeting the definition of an AE or SAE. 
9.1 
Definitions 
9.1.1 
Adverse Events 
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a 
pharmaceutical product and may not necessarily have a causal relationship with the administered treatment. 
An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, 
for example), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product. During the study, an AE can also 
occur outside the time that the investigational product(s) was given (e.g., during a washout period).  
Pre-existing conditions, diseases, or disorders are not considered AEs unless there is a change in intensity, 
frequency, or quality. 
9.1.2 
Serious Adverse Events and Serious Unexpected Adverse Events 
A SAE is any untoward medical occurrence that  
 
results in death, 
 
is life-threatening (at the time of the event), 

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 
requires in-patient hospitalization or prolongation of existing hospitalization, 
 
results in persistent or significant disability/incapacity, or 
 
is a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life-threatening, or require hospitalization may be 
considered a serious adverse drug experience when, based upon appropriate medical judgment, they may 
jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes 
listed in this definition. 
A serious and unexpected AE is SAE that is not identified in nature, severity, or frequency in the risk 
information set out in the Product Monograph or on the label of the investigational material. 
9.1.3 
Clinical Laboratory Abnormalities and Other Abnormal Assessments 
Clinically significant abnormal laboratory findings (e.g., from clinical chemistry, hematology, or urinalysis) 
or other abnormal assessments (e.g., from vital signs or ECG) that are judged as clinically significant by the 
investigator or designee will be recorded as AEs or SAEs, if they meet the definitions provided in Sections 
9.1.1 and 9.1.2. Furthermore, clinically significant abnormal laboratory findings or other abnormal 
assessments that are present at baseline and significantly worsen following the start of the study will be 
reported as AEs or SAEs. However, clinically significant abnormal findings associated with the disease 
being studied that are present at the start of the study and do not worsen will not be reported as AEs or 
SAEs, unless the investigator or designee judges them as more severe than expected for the subject’s 
condition. 
The investigator will exercise his or her medical and scientific judgment in deciding whether an abnormal 
laboratory finding or other abnormal assessment is clinically significant. 
9.2 
Evaluation of Adverse Events and Serious Adverse Events 
9.2.1 
Classification of Adverse Event Severity 
The investigator or designee is responsible for making an assessment as to the severity of an AE (see Table 
1). If there is insufficient information to determine severity, the AE must still be reported. 
Table 1.  
Classifications for Adverse Event Severity 
Classification 
Definition 
Mild 
An event that is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual 
activities of daily living. 
Moderate 
An event that is alleviated with additional specific therapeutic intervention. 
The event interferes with usual activities of daily living, causing discomfort 
but poses no significant or permanent risk of harm to the subject. 
Severe 
An event that requires intensive therapeutic intervention. The event interrupts 
usual activities of daily living or significantly affects clinical status. The event 
poses a significant risk of harm to the subject and hospitalization may be 
required. 
 

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9.2.2 
Classification of Adverse Event Causality 
For each recorded AE, the investigator or designee must make an assessment of causality based on the 
following criteria (see Table 3) to determine the relationship between the AE and study material. 
Table 2.  
Classifications for Adverse Event Causality (i.e., relationship to study drug) 
Classification 
Definition 
Unrelated 
The AE or SAE is judged to be clearly and incontrovertibly due only to 
extraneous causes (e.g., disease, environment, etc.) and do not meet the 
criteria for study drug relationship listed under probable, possible, or unlikely. 
Unlikely 
The AE or SAE is unlikely related to the study drug, when the AE or SAE 
 
does not follow a reasonable temporal sequence from administration of 
the study drug 
 
may readily have been produced by the subject’s clinical state, 
environmental, or toxic factors, or other modes of therapy administered 
to the subject 
 
does not follow a known pattern of response to the study material 
 
does not reappear or worsen when the study material is re-administered 
Possible 
The AE or SAE is possibly related to the study material, when the connection 
to the study material appears unlikely but cannot be ruled out with certainty. 
This causal relationship is assigned when the AE or SAE  
 
follows a reasonable temporal sequence from administration of the study 
material 
 
may have been produced by the subject’s clinical state, environmental, 
or toxic factors, or other modes of therapy administered to the subject 
 
follows a pattern of response to the suspected study material 
Probable 
The AE or SAE probably related to the study material, when the connection to 
study material can be made with a high degree of certainty. This causal 
relationship is assigned when the AE or SAE 
 
follows a reasonable temporal sequence from administration of the study 
material 
 
cannot be reasonably explained by the known characteristics of the 
subject’s clinical state, environmental, or toxic factors, or other modes of 
therapy administered to the subject. 
 
disappears or decreases on cessation or reduction in dose (note that are 
important exceptions when an AE or SAE does not disappear upon 
discontinuation of the study material, yet relatedness clearly exists, e.g., 
bone marrow depression or tardive dyskinesias) 
 
follows a known pattern of response to the suspected study material 
reappears upon re-challenge 
 

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9.3 
Reporting Procedures 
9.3.1 
Contacting Sponsor Regarding Safety 
When issues regarding safety arise (e.g., SAE or a serious unexpected AE), the sponsor must be contacted 
within an appropriate timeframe.  
DeCell assumes responsibility for appropriate reporting of AEs to the regulatory authorities. DeCell will 
also report to each investigator all SAEs that are unlisted and associated with the use of the study product. 
The investigator must report these events to the appropriate IRB that approved the protocol (unless 
otherwise required and documented by the IRB). 
9.3.2 
Reporting Period 
AEs and SAEs will be assessed and recorded in the source documentation from the time of first contact with 
the subject (e.g., at the Screening) until the end of the Follow-Up phase of the study. AEs that occur after 
medical screening and prior to administration of the first dose of study drug will be recorded in the source 
documentation as Baseline Signs and Symptoms. 
All unresolved AEs will be followed up for a minimum of 14 days after the subject’s final study visit, unless 
the investigator’s judgment dictates otherwise, the event has resolved or stabilized before the 14-day period, 
or the subject is lost to follow-up. All SAEs will be followed until resolved or until a stable status has been 
achieved. 
Investigators are not obligated to actively seek AEs or SAEs in former study subjects that occur following 
the Follow-up period. However, if the investigator or designee learns of any AE or SAE at any time after a 
subject has been discharged from the study and the event is considered as reasonably related to the study 
drug, the investigator will notify DeCell. 
9.3.3 
Any Adverse Event 
All post-treatment complications and adverse events will be recorded on the appropriate case report form. 
 
9.3.4 
Any Serious Adverse Event 
Any SAE—expected or unexpected, irrespective of relationship to study treatments, including death due to 
any cause—experienced by a study subject will be reported to DeCell by the investigator or designee within 
24 hours of learning of the event.  
All additional follow-up evaluations for SAEs will be reported to DeCell. 
9.3.5 
Follow-Up of Adverse Events and Serious Adverse Events 
All AEs and SAEs that have not resolved by the end of the study or have not resolved upon discontinuation 
of the subject’s participation in the study must be followed-up until one of the following occurs: 
 
the event resolves 
 
the event stabilizes 
 
the event returns to a baseline value, if a baseline value is available 

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 
the event can be attributed to agents other than the study drug or to factors unrelated to study conduct 
When it becomes unlikely that any additional information can be obtained (e.g., subject or health care 
practitioner refuses to provide additional information, the subject is lost to follow-up), the investigator or 
designee will ensure that the follow-up includes any pertinent supplemental investigations (e.g., laboratory 
tests or investigations, histopathological examinations or consultation with other health care professionals) 
to elucidate the nature and/or causality of the AE or SAE. 
 
9.4 
Insurance for Patients 
DeCell maintains clinical trial insurance for this study in accordance with the laws and regulations of 
Canada. 

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10. REFERENCES 
(1) International Diabetes Federation (IWGDF), (2012) 
(2) Rogers et al, JAPMA, 2008;98:166 
(3) The Lancet (cover), Nov. 2005 
(4) Armstrong, et al, Diabetes Care 2013, In Press 
(5) Canadian Diabetes Association Website, Accessed February 2014 
(6) Canadian Diabetes Association, “At the Tipping Point: Diabetes in Nova Scotia”, 2013 
(7) Canadian Diabetes Association, Website News, “Diabetes Wellness Plan is on the Election Agenda in 
Nova Scotia”, Monday, Sept. 16, 2013 
(8) “The Diabetic Foot in Nova Scotia: Challenges and Opportunities”, May 2007, Diabetes Care Program 
of Nova Scotia 
(9) “Audit of Time Taken to Heal Diabetic Foot Ulcers” Robertshaw, L, Robertshaw, D.A., and Whyte, I., 
Practical Diabetes Int., 2001; 18(1):6-9, 
(10) “Percent Change in Wound Area of Diabetic Foot Ulcers Over a 4-week Period is a Robust Predictor of 
Complete Healing in a 12-week Prospective Trial.” Sheehan P, Jones P, Caselli A, et al. Diabetes Care 2003; 
26(6): 1879-82. 
(11) “Risk Factors for Foot Infections in Individuals With Diabetes.” Lavery et al., Diabetes Care. 2006; 
29:1288-93. 
(12) “Consensus development conference on diabetic foot wound care: April 7-8,1999,Boston, MA. 
American Diabetes Association. Diabetes Care.” 1999;22(8):1354-1360. 
(13) “The Costs of Diabetic Foot: The Economic case for the Limb Salvage Team” Driver, V.R., Fabbi, M., 
Lavery, L.A., and Gibbons, G. J. Vasc. Surg. 2010; 52:17S-22S 
(14) “Advanced Wound Care Therapies for Nonhealing Diabetic, Venous, and Arterial Ulcers: A Systematic 
Review” Greer, N., Foman, N.A., MacDonald, R., Dorrian, J., Fitzgerals, P., Rutks, I., and Wilt, T.J. Annals 
of Internal Medicine 2013;159:532-542 
(15) “Shire Executes Agreement to Divest Dermagraft”, Shire press release, January 17, 2014 
(16) “Quantification of DNA in Biologic Scaffold Materials” Gilbert, T.W., Freund, J.M, and Badylak, S.F., 
J Surg Res 2009; 152:135-19 
(17) “In-Vivo and In-Vitro Histological Evaluation of Two Commercially Available Acellular Dermal 
Matrices” Faleris, J.A., Hernandez, R.M.C., Wetzel, W., Dodds, R., Greenspan, D.C. Hernia 2011;15:147-
156 
18) “Human Monocyte Activation by Biologic and Biodegradable Meshes In Vitro” Orenstein, S., Quao, Y., 
Kaur, M., Klueh, U., Kreutzer, D., Novitsky, Y. Surg Endosc 2009; 24:805-811 
(19) “In Vitro Acitvation of Human Peripheral Blood Mononuclear Cells Induces by Human Biologic 
Meshes” Orenstein, S., Quao, Y., Kaur, M., Klueh, U., Kreutzer, D., Novitsky, Y., J Surg Res 2010; 158:10-
14 

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(20) “Methods for Tissue Decellularization”, Paul Frank Gratzer, Canadian Application, International 
Reference no. PCT/IB2077/001538, Entry date August 21, 2012; “Methods for Tissue Decellularization”, 
Paul Frank Gratzer, U.S. Application no. 13/580,367, Entry date August 21, 2012 
(21) Guidance for Industry Chronic Cutaneous Ulcer and Burn Wounds —Developing Products for 
Treatment , U.S. Department of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for 
Devices and Radiological Health (CDRH), June 2006 
(22) “The Use of an Acellular Dermal Regenerative Tissue Matrix in the Treatment of Lower Extremity 
Wounds: A Prospective 16-week Pilot Study” Brigido, S.A., Int Wound J, 2006;3:181—187 
(23) “Benchmarks for Interpretation of Score Differences on the SF-36 Health Survey for Patients with 
Diabetes.” Bjorner, J.B., Wolden, M.L., Gundgaard, J., and Miller, K.A. Value in Health 2013; 16: 993-1000 
(24) “Digital Imaging of Wounds: Are Measurements Reproducible Among Observers?” Quan SY, Lazarus 
GS, Kohli AR, et al. Int J Low Extrem Wounds 2007; 6:245–8. 
(25) “Surrogate End Points for the Treatment of Diabetic Neuropathic Foot Ulcers” Margolis, D.J., Gelfand, 
J.M., Hoffstad, O., and Berlin, J.A. Diabetes Care 2003; 26:1696-1700  
(26) “Healing of Diabetic Neuropathic Foot Ulcers Receiving Standard of Care: A Meta-Analysis” 
Margolis, DJ., Kantor, J., and Berkin, J.A. Diabetes Care 1999;22:692-695 
 

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11. APPENDICES 
If not included with this version, please refer to earlier versions of the protocol for appendices 
referenced herein. 
 
 
 

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APPENDIX 1:  DermGEN Characteristics 
 
 
 
 

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APPENDIX 2: Health Canada’s Approval To Use DermGEN 
 
 
 
 

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APPENDIX 3: Informed Consent Document 
 
 
 
 

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APPENDIX 4:  The Leg Ulcer Measurement Tool [LUMT] 
 
 
 
 

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APPENDIX 5: The SF-12 Health Survey 
 
 

 
 
 
1 
 
Clinical Trial 
 
Informed Consent Form  
 
STUDY TITLE: 
A Pilot Safety and Efficacy Study of DermGEN Dermal 
Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers  
 
 
 
CLINICAL STUDY REGISTRATION NUMBER: NCT02184455. 
 
 
 
PRINCIPAL 
     Dr Mark Glazebrook    
INVESTIGATOR:        QEII Health Sciences Centre 
                                     Halifax Infirmary Room 4867 
                                     1796 Summer Street  
                                     Halifax, Nova Scotia B3H 1V7  
                                     Telephone: (902) 473-7137 
 
 
 
 
ASSOCIATE  
    Dr. Jason Williams 
INVESTIGATORS.      Halifax Infirmary  
                                     1796 Summer Street  
                                     Halifax, Nova Scotia B3H 1V7  
                                     Telephone: (902) 473- 
 
 
 
 
STUDY SPONSOR:     DeCell Technologies Inc.  
 
  
 
 
 
 
 
 
FUNDING AGENCY:    DeCell Technologies Inc. , CIHR 
 
 
 
 

 
 
 
2 
 
 
 
 
1. Introduction	  
You have been invited to take part in a research study. A research study is a way of 
gathering information on a treatment, procedure or medical device or to answer a 
question about something that is not well understood.  Taking part in this study is 
voluntary. It is up to you to decide whether to be in the study or not. Before you decide, 
you need to understand what the study is for, what risks you might take and what 
benefits you might receive. This informed consent form explains the study. 
You may take as much time as you wish to decide whether or not to participate.  Feel 
free to discuss it with your friends and family, or your family doctor. The study staff will 
tell you if there are any study timelines for making your decision 
 
Please ask the study staff or the principal investigator to clarify anything you do not 
understand or would like to know more about.  Make sure all your questions are 
answered to your satisfaction before deciding whether to participate in this research 
study.   
 
The researchers will: 
• Discuss the study with you 
• Answer your questions 
• Keep confidential any information which could identify you personally 
• Be available during the study to deal with problems and answer questions 
 
You are being asked to consider participating in this study because you have a diabetic 
foot ulcer and may benefit from this new grafting product. 
 
If you decide not to take part or if you leave the study early, your usual health care will 
not be affected. 
 
2. Why is this study being conducted? 
You are being asked to take part in this study because you are being treated for a 
diabetic foot ulcer. This study is being done to compare this treatment to existing 
treatment of diabetic foot ulcers and compare the time it takes for these ulcers to heal.   
3.	  What	  Is	  Being	  Tested?	  
The purpose of this clinical trial is to perform a limited pilot study (which means a small 
number of patients (20) to determine the effectiveness and safety of DermGEN graft 
material in the treatment of non-healing diabetic foot ulcers.  

 
 
 
3 
 
4.	  How	  Long	  Will	  I	  Be	  In	  The	  Study?	  
After enrollment in this study, your doctor will ask you to visit the clinic for several follow 
up visits.  These visits will happen at: 1, 2, 3, 4, 12, 20 weeks, the last study visit will be 
6 months from the date of your first visit. Each follow-up appointment will take 30-60 
minutes or less.   
5.	  How	  Many	  People	  Will	  Take	  Part	  In	  This	  Study?	  
A total of 20 patients will be enrolled in this study, with patients enrolled in each of the 
following participating centers: Halifax and Toronto. The study will be centrally managed 
at the Halifax site. Twelve (12) patients will be enrolled locally at the Halifax Infirmary 
site and eight (8) at the Toronto site. 
6.	  How	  Is	  The	  Study	  Being	  Done?	  
 
Prior to being enrolled for participation in the study, you will be asked to read and 
voluntarily sign this Informed Consent.  Your surgeon will explain the application of the 
DermGen graft and the procedure with you.  You will have an opportunity to ask and 
receive answers from your surgeon about any questions you may have regarding the 
procedure, the graft, this research study, or this document.  You will undergo routine 
tests and procedures for your diabetes and your diabetic ulcer at your clinic 
appointment, including baseline blood work and a physical examination of your effected 
foot.  As part of this study you will be asked to answer questions about your pain, 
function and general health at each visit. Following the completion of your medical 
evaluation, you will be scheduled for the application of the graft material. In this study, 
you will receive the same treatment as other patients enrolled in this study. Each follow-
up appointment will take 30-60 minutes or less. You will be asked to return to the QEII 
for 6 visits over the next 6 months.  A record of your diabetic ulcer will be kept by the 
research staff at each visit. 
7.	  What	  Will	  Happen	  If	  I	  Take	  Part	  In	  This	  Study?	  
 
SCREENING 
 
If you want to be in this study and sign this consent form, you will be asked to have 
some tests done to see if you can take part. This is called screening. It is possible that 
the tests will show that you can't be in the study. There may be other tests done as part 
of usual care. The research team will discuss these with you.  
 
The research study screening tests that will be done are: 
• General Health Assessment – your doctor will examine your foot ulcer and 
review standard blood work to confirm you are eligible for this study.  
 
STUDY 
We will do the following as part of the trial: 

 
 
 
4 
 
. 
 
• Foot Exam – your doctor will examine your foot ulcer for signs of infection, 
circulatory status, the size of your foot ulcer at each visit. 
•  A photograph will be done of the diabetic ulcer at each visit. 
• The questionnaires you will answer at visits 1,5,6,7  
• Application of the graft to the diabetic ulcer at visit 2 
. 
 
FOLLOW UP 
These visits will happen at: 1, 2, 3, 4, 12, 20 weeks, the last study visit will be 6 months 
from the date of your first visit. 
Of course you may ask not to have further tests done or to participate in any additional 
trial procedures at any time. 
It is important that you tell the Principal Investigator about any drugs or medicines you 
are taking or wish to take. You must also tell the Principal Investigator about anything 
unusual that is happening with your health. This includes any medical problems that 
seem to be getting worse.  If you have to see another doctor or have to go to a hospital, 
you must let the doctors know that you are in a research study.  You should also tell 
your own doctor as quickly as possible, for your safety. 
8.	  What	  About	  Birth	  Control	  and	  Pregnancy?	  
 The effects of study device on unborn babies or sperm are unknown. You should not 
take part in this study if you are pregnant or planning to become pregnant.    
 
Birth Control: If you and your partner are of childbearing potential (physically able to 
have children) and you are sexually active, it is important that you practice an 
acceptable method of birth control during this study   
 
Visit 
Visit 1 
Baseline 
 
  
Visit 2 
Week1 
 
Visit 3 
Week 2 
 
Visit 4 
Week3 
 
Visit 5 
Week 4 
 
Visit 6 
Week 12 
 
Visit 7 
Week 20 
 
Time 
30 min 
60 min 
30 min  
 30 min 
30 min 
30 min 
30 min 
Informed consent 
X 
 
 
 
 
 
 
Medical history 
Review  
(MDLUC Hx form) 
X 
 
 
 
X 
X 
X 
Ulcer assessment 
record. 
( including digital 
record) -Photograph 
X 
X 
X 
X 
X 
X 
X 
Questionnaires 
SF 36 
X 
 
 
 
X 
X 
X 
Review and report 
adverse events 
 
X 
X 
X 
X 
X 
X 
Application of graft 
 
X 
 
 
 
 
 

 
 
 
5 
 
 Pregnancy: If you get pregnant during the study you may need to stop participating in 
the study. 
9. Are There Risks To The Study? 
 
There are risks with this, or any study. To give you the most complete information 
available, we have listed many possible risks, which may appear alarming. We do not 
want to alarm you but we do want to make sure that if you decide to try the study, you 
have had a chance to think about the risks carefully. Please also be aware that there may 
be risks in participating in this study that we do not know about yet.  
 
Possible complications with the use of the DermGEN graft include the following; 
Uncommon  “Uncommon risks (1 or more out of every 1000 people but less than 1 out 
of every 100 people have experienced the following):” 
 
• Maceration which is softening of the skin due to prolonged exposure to wetness 
• specific or non-specific immune response 
•  infection 
• the graft does not adhere to the surface 
 
Given the nature of the treatment and location and type of wound being treated, most 
adverse events may be stopped through the cessation of treatment with graft removal..   
 
QUESTIONNAIRES:  You may find the interviews and questionnaires you receive 
during the course of the study upsetting or distressing. You may not like all of the 
questions that you will be asked. You do not have to answer those questions you find 
too distressing. 
 
The study device may interfere with medications, both prescribed and over the counter 
that you are currently taking. You should ask the Principal Investigator if the study 
device could interfere with your medications before consenting to be in this study. You 
should also consult with the Principal Investigator or members of the research team 
before taking any new medications.  
 
You will be told about any new information that might reasonably affect your willingness 
to continue to participate in this study as soon as the information becomes available to 
the study staff.   
10.	  	  Are	  There	  Benefits	  Of	  Participating	  In	  This	  Study?	  
You may or may not benefit directly from participating in this study.  Your participation 
may help other people with a diabetic ulcer in the future.   
11.	  Are	  There	  Other	  Choices?	  
If you decide not to participate in this study, other treatment choices may be available.  
Your other choices may include: 

 
 
 
6 
 
• Getting treatment or care for your diabetic ulcer without being in a study 
Talk to your doctor about your choices before you decide if you will take part in this 
study. 
 
New devices become available for this sort of condition at different times and in different 
parts of the world. Like many other hospitals, we do not feel it is helpful to test more 
than one experimental treatment for the same condition at the same time in the same 
person. This could even be dangerous. So you will not undergo two experimental 
procedures during the same time period. 
 
You are free to seek other opinions or choices in other hospitals or cities if you wish. 
12.	  What	  Happens	  at	  the	  End	  of	  the	  Study?	  
You will be followed by your othopaedic surgeon after the study end as part of clinical 
practice. There is no charge for this device.  
13.	  What	  Are	  My	  Responsibilities?	  
As a study participant you will be expected to: 
• Follow the directions of the Principal Investigator 
• Report all medications being taken or that you plan on taking 
• Report any changes in your health to the Principal Investigator 
• Report any problems that you experience that you think might be related 
to participating in the study 
• Return for scheduled appointments. 
14.	  Can	  My	  Participation	  in	  this	  Study	  End	  Early?	  
The study sponsor, the Capital Health Research Ethics Board, Health Canada, or the 
Principal Investigator have the right to stop patient recruitment or cancel the study at 
any time. 
 
The principal investigator may decide to remove you from this study without your 
consent for any of the following reasons: 
 
 The treatment does not work for you; 
 You do not follow the directions of the Principal Investigator; 
 In the opinion of the Principal Investigator you are experiencing side effects that are 
harmful to your health or well-being; 
 There is new information that shows that being in this study is not in your best 
interests; 
 You plan to become pregnant, plan to discontinue acceptable birth control, or you 
become pregnant. 
 When there is evidence that the study should be stopped due to safety reasons or 
lack of treatment effect (when the treatment is not working well). 
 

 
 
 
7 
 
If you are removed from this study, a member of the study team/principal investigator 
will discuss the reasons with you and plans will be made for your continued care outside 
of the study. 
 
You can also choose to end your participation at any time without having to provide a 
reason.  If you choose to withdraw from this study by providing notice to the study 
doctor, your choice will have no effect on your current or future medical treatment and 
healthcare.  Your health records may be examined in connection with this study or 
further analyses related to it. Your health records will only be made available as 
described above. However the above agencies, including the sponsor, will only look at 
and use study related records up to the date of your withdrawal from the study, except 
where it is necessary to ensure that the study is scientifically reliable and to report side 
effects associated with the study medication as required by regulatory authorities.  
 
 If you withdraw your consent, the information about you that was/were collected before 
you left the study will still be used.  No new information about you will be collected 
without your permission.  
15.	  What	  About	  New	  Information?	  
 
It is possible that new information may become available while you are in the study 
about some new treatment for your condition. You will be told about any other new 
information that might affect your health, welfare, or willingness to stay in the study and 
will be asked whether you wish to continue taking part in the study or not. 
16.	  Will	  It	  Cost	  Me	  Anything?	  
Compensation 
 
You will not have to pay for any study device while participating in this study; you will 
not be paid to be in the study. 
 
Research Related Injury 
 
If you become ill or injured as a direct result of participating in this study, necessary 
medical treatment will be available at no additional cost to you. Your signature on this 
form only indicates that you have understood to your satisfaction the information 
regarding your participation in the study and agree to participate in the study. In no way 
does this waive your legal rights nor release the Principal Investigator, the research 
team, the study sponsor or involved institutions from their legal and professional 
responsibilities.   
 
17.	  What	  About	  My	  Privacy	  and	  Confidentiality?	  	   	  
	  
 
Protecting your privacy is an important part of this study. Every effort to protect your 
privacy will be made. No identifying information (such as your name or hospital number) 

 
 
 
8 
 
will be sent outside of this health care facility. If the results of this study are presented to 
the public, nobody will be able to tell that you were in the study. 
 
However, complete privacy cannot be guaranteed. For example, the investigator may 
be required by law to allow access to research records. A copy of this consent form will 
be put in your health record. Your family doctor will be told that you are taking part in 
this study. 
 
If you decide to participate in this study, the investigator(s) and study staff will look at 
your personal health information and collect only the information they need for this 
study.  “Personal health information” is health information about you that could identify 
you because it includes information such as your; 
• Name,  
• Address,  
• Telephone number,  
• Age or month/year of birth (MM/YY),  
• Information from the study interviews and questionnaires; 
• New and existing medical records, or  
• The types, dates and results of various tests and procedures.  
 
When you sign this consent form, you give us permission to: 
 
• Collect information from you 
• Collect information from your health record 
• Share information with the people conducting the study 
• Share information with the people responsible for protecting your safety 
while participating in this research. 
 
Access to Records 
 
Other people, during visits to this health care facility, may need to look at your personal  
health  information to check that the information collected for the study is correct and to 
make sure the study followed the required laws and guidelines.  These people might 
include: 
• DeCell Technologies Inc., the company that makes the DermGen graft, 
and its representatives and partner companies (inside and outside of 
Canada); 
• The Capital Health Research Ethics Board (CHREB) and people working 
for or with the CHREB because they oversee the ethical conduct of 
research studies at Capital Health; 
• Representatives of Health Canada, the group of people who oversee the 
use of drugs in research in Canada. 
 
 
 
 

 
 
 
9 
 
 
Use of Your Study Information 
 
The research team will collect and use only the information they need to judge the 
safety and usefulness of the device. The sponsor and companies working for and with 
the sponsor will use the information collected about you during the study, only for 
scientific research purposes. “Study data" is health information about you that is 
collected for the study, but that does not directly identify you.   
 
Any study data about you that is sent outside of Capital Health will have a code and will 
not contain your name or address, or any information that directly identifies you.   
 
You also allow the collection, reporting and transfer of your anonymous personal health 
information and study data to: 
 
• The sponsor and companies working for and with the sponsor; and 
• Regulatory authorities within and outside Canada. 
 
Study data that is sent outside of the hospital will be used for the research purposes 
explained in this consent form. The investigator(s), study staff and the other people 
listed above will keep the information they see or receive about you confidential, to the 
extent permitted by applicable laws. Even though the risk of identifying you from the 
study data is very small, it can never be completely eliminated. 
 
The research team will keep any personal health information about you in a secure and 
confidential location for 7 years and then destroy it according to Capital Health policy.  
Your personal health information will not be shared with others without your permission.  
 
After your part in the study ends, we may continue to review your health records for 
safety and data accuracy until the study is finished. 
 
When the results of this study are published, your identity will not be disclosed.  
 
You have the right to be informed of the results of this study once the entire study is 
complete.  If you would like to be informed of the results of this study, please contact 
Trish Francis RN Orthopedic Research dept @ 902 473 5993. 
The Research Ethics Board and people working for or with the Research Ethics Board 
may also contact you personally for quality assurance purposes. 
 
 
Your Access to Records 
You may ask the study doctor to see the information that has been collected about you. 
You may ask to make corrections to this information by talking with a member of the 
research team.  
 

 
 
 
10 
 
 A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Web site will include a summary of the results. You can search this Web site 
at any time.  
18.	  Declaration	  of	  Financial	  Interest	  
The sponsor is reimbursing the Principal Investigator and/or the Principal Investigator’s 
institution to conduct this study. The amount of payment is sufficient to cover the costs 
of conducting the study. 
 
19.	  What	  About	  Questions	  or	  Problems?	  
For further information about the study call Dr. Mark Glazebrook.  Dr. Glazebrook is in 
charge of this study at this hospital (he is the “Principal Investigator”). Dr. Mark 
Glazebrook’s work telephone number is (902) 473-5993. If you experience any 
symptoms or possible side effects or other medical problems, please let the Principal 
Investigator know immediately. 
 
If you can't reach the Principal Investigator, or it is after regular business hours, speak 
to the emergency physician on call. The afterhour’s number is (902) 473-2222. 
This doctor may not be the one you usually see while in this study. Please call the 
Principal Investigator or research coordinator the next business day to tell them about 
the possible side effects or other medical problems you experienced. 
 
The Principal Investigator is Dr. Mark Glazebrook 
Telephone: (902) 473-7137 
Your Research Coordinator is Trish Francis RN. 
Telephone: (902) 473-5993 
	  
20.	  What	  Are	  My	  Rights?	  
You have the right to receive all information that could help you make a decision about 
participating in this study. You also have the right to ask questions about this study and 
your rights as a research participant, and to have them answered to your satisfaction 
before you make any decision. You also have the right to ask questions and to receive 
answers throughout this study.  
 
After you have signed this consent form you will be given a copy.  
If you have any questions about your rights as a research participant, contact the 
Patient Representative at (902) 473-2133. 
 
In the next part you will be asked if you agree (consent) to join this study. If the answer 
is “yes”, you will need to sign the form. 

 
 
 
11 
 
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  21.	  Consent	  Form	  Signature	  Page	  
	  
I have reviewed all of the information in this consent form related to the trial called:  
A Pilot Safety and Efficacy Study of DermGEN Dermal Regeneration Scaffold for 
the Treatment of Diabetic Foot Ulcers  
 
I have been given the opportunity to discuss this study. All of my questions have been 
answered to my satisfaction. I authorize access to my personal health information, 
medical record and research study data as explained in this form. 
 
This signature on this consent form means that I agree to take part in this study. I 
understand that I am free to withdraw at any time without affecting my future care. 
 
 
 
______________________________        _______________________  
_____  /  ______  /  ____ 
Signature of Participant                     
    Name (Printed) 
 
Year    Month    Day*  
 
 
 
______________________________        _______________________  
_____  /  ______  /  ____ 
Witness to Participant’s 
 
    Name (Printed) 
 
Year    Month    Day* 
Signature 
 
 
______________________________        _______________________  
_____  /  ______  /  ____ 
Signature of Investigator                     
    Name (Printed) 
 
Year    Month    Day* 
 
 
 
______________________________        _______________________  
_____  /  ______  /  ____ 
Signature of Person Conducting    
    Name (Printed) 
 
Year    Month    Day* 
Consent Discussion 
 
______________________________        _______________________  
_____  /  ______  /  ____ 
Signature of Participant’s 
 
    Name (Printed) 
 
Year    Month    Day* 
Substitute Decision Maker  
 
If the consent discussion has been conducted in a language other than English, please indicate:  
_______________ 
         Language 
_____________________________        _______________________  
_____  /  ______  /  ____ 
Signature of Translator 
 
     Name (Printed) 
 
Year    Month    Day* 
*Note:  Please fill in the dates personally 
 
 
I Will Be Given a Signed Copy of This Consent Form 
Thank you for your time and patience!