A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Phase: NA
Conditions: Wound
Sponsor: Medline Industries



Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
2 
 
Contents 
INVESTIGATOR ACKNOWLEDGMENT SIGNATURE ................................................................................ 4 
1. 
PROTOCOL SUMMARY ....................................................................................................................... 7 
1.1. 
Synopsis ........................................................................................................................................ 7 
1.2. 
Schedule of Activities (SOA) ......................................................................................................... 9 
2. 
INTRODUCTION ................................................................................................................................. 10 
2.1. 
Background & Rationale ............................................................................................................. 10 
2.2. 
Investigational Product ................................................................................................................ 10 
2.3. 
Risk/Benefit Profile ...................................................................................................................... 11 
2.3.1. 
Potential Study Risks .......................................................................................................... 11 
2.3.2. 
Potential Study Benefits ...................................................................................................... 11 
2.3.3. 
Assessment of Potential Risk/Benefit Profile ...................................................................... 11 
3. 
OBJECTIVES AND ENDPOINTS ........................................................................................................ 11 
4. 
STUDY DESIGN .................................................................................................................................. 12 
4.1. 
Overall Design ............................................................................................................................. 12 
4.2. 
End of Study Definition ................................................................................................................ 12 
5. 
STUDY POPULATION......................................................................................................................... 12 
5.1. 
Inclusion Criteria ......................................................................................................................... 12 
5.2. 
Exclusion Criteria ........................................................................................................................ 12 
5.3. 
Strategies for Recruitment and Retention ................................................................................... 13 
6. 
STUDY PROCEDURES AND ASSESSMENTS ................................................................................. 13 
6.1. 
Day -1 – Pre-screening ............................................................................................................... 13 
6.2. 
Day 0 - Informed Consent and Screening Visit ........................................................................... 13 
6.2.1. 
Informed Consent ................................................................................................................ 13 
6.2.2. 
Screening ............................................................................................................................ 13 
6.3. 
Day 1 – Initial Visit ....................................................................................................................... 14 
6.3.1. 
Demographic and Baseline Data Collection ....................................................................... 14 
6.3.2. 
Photograph of Wound and Wound Size Measurement....................................................... 14 

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6.3.3. 
Pain Assessment................................................................................................................. 14 
6.3.4. 
Bates-Jensen Wound Assessment Tool ............................................................................. 14 
6.3.5. 
Dressing Application ........................................................................................................... 15 
6.4. 
Dressing Change Visit ................................................................................................................. 15 
6.5. 
Wound Assessment Visit ............................................................................................................ 15 
6.6. 
Final Visit ..................................................................................................................................... 15 
7. 
ADVERSE EVENTS ............................................................................................................................ 15 
7.1. 
Definition of Adverse Event ......................................................................................................... 15 
7.2. 
Definition of Serious Adverse Event ........................................................................................... 15 
7.3. 
Severity of Adverse Event ........................................................................................................... 16 
7.4. 
Relatedness of Adverse Event and Serious Adverse Event ....................................................... 16 
7.5. 
Expectedness .............................................................................................................................. 16 
7.6. 
Adverse Event Reporting ............................................................................................................ 16 
7.7. 
Serious Adverse Event Reporting ............................................................................................... 17 
8. 
STATISTICAL CONSIDERATIONS ..................................................................................................... 17 
8.1. 
Sample Size Determination ......................................................................................................... 17 
8.2. 
Populations for Analyses ............................................................................................................. 17 
8.3. 
Data Analysis .............................................................................................................................. 17 
8.3.1. 
Wound Size Analysis .......................................................................................................... 17 
8.3.2. 
BWAT Analysis .................................................................................................................... 18 
8.3.3. 
Pain Scale Analysis ............................................................................................................. 18 
9. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ............................... 18 
9.1. 
Key Roles and Study Governance .............................................................................................. 18 
9.2. 
Clinical Monitoring ....................................................................................................................... 18 
9.3. 
Regulatory and Ethical Considerations ....................................................................................... 19 
9.3.1. 
Confidentiality and Privacy .................................................................................................. 19 
9.3.2. 
Safety Oversight .................................................................................................................. 20 
9.3.3. 
Data Handling and Record Keeping.................................................................................... 20 
9.3.4. 
Study Records Retention .................................................................................................... 21 

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9.3.5. 
Study Discontinuation ......................................................................................................... 21 
9.3.6. 
Study Closeout .................................................................................................................... 21 
9.3.7. 
Conflict of Interest Policy ..................................................................................................... 22 
9.4. 
Protocol Deviations ..................................................................................................................... 22 
9.5. 
Abbreviations and Terms ............................................................................................................ 22 
10. 
REFERENCES ................................................................................................................................ 22 
11. 
APPENDIX ...................................................................................................................................... 24 
11.1. 
Products used in study ................................................................................................................ 24 
11.1.1. 
Investigational Product: Puracol® Ultra Powder Label and Instructions for Use ................. 24 
11.1.2. 
Optifoam® Gentle Silicone Border Dressings ...................................................................... 26 
11.1.3. 
CoFlex® TLC Two Layer Compression Bandage System ................................................... 27 
11.2. 
Screening Forms ......................................................................................................................... 28 
11.2.1. 
Pre-Screening Form ............................................................................................................ 28 
11.2.2. 
Screening Form ................................................................................................................... 29 
11.3. 
Case Report Forms ..................................................................................................................... 31 
11.3.1. 
Initial Visit Case Report Form ............................................................................................. 31 
11.3.2. 
Wound Photo Case Report Form ........................................................................................ 32 
11.3.3. 
Bates-Jensen Wound Assessment Tool (BWAT) ............................................................... 33 
11.3.3.1. 
BWAT Instructions for use .............................................................................................. 33 
11.3.3.2. 
BWAT Case Report Form ............................................................................................... 35 
11.3.4. 
Dressing Log Case Report Form ........................................................................................ 37 
11.4. 
Adverse Event Form ................................................................................................................... 43 
11.5. 
Serious Adverse Event ................................................................................................................ 44 
 
INVESTIGATOR ACKNOWLEDGMENT SIGNATURE 
 
 
I agree to conduct the study in accordance with the relevant, current protocol and 
will make changes in the protocol only after notifying the Sponsor, except when 
necessary to protect the safety, rights, or welfare of subjects. 

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 
I agree to personally conduct and supervise the investigation as described within. 
 
I agree to inform all subjects that the device is being used for the purposes of an 
investigational study.  
 
I will ensure that requirements relating to obtaining informed consent in the 
guidelines for Good Clinical Practices, and 21 CFR Part 50 and institutional review 
board (IRB) review and approval in 21 CFR Part 56 are met. 
 
I agree to report to the Sponsor, IRB and/or Ethics Committee, according to the 
protocol, adverse experiences that occur during the course of the investigation in 
accordance with  guidelines for Good Clinical Practices, and 21 CFR 812. 
 
I have read and understand the information in the protocol, including the potential 
risks. 
 
I agree to maintain adequate and accurate records in accordance with guidelines for 
Good Clinical Practices and 21 CFR 812.140 and to make those records available 
for inspection. 
 
I will ensure that an IRB compliant with the requirements of guidelines for Good 
Clinical Practices and 21 CFR Part 56 will be responsible for the initial and 
continuing review and approval of the clinical investigation. I also agree to 
promptly report to the IRB all changes in the research activity and all unanticipated 
problems involving risks to human subjects or others.  
 
I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements in the guidelines for Good 
Clinical Practices, and the Code of Federal Regulations. 
I have received and reviewed this Investigational Plan. I will conduct the study as described. 
__________________________________________     
_______________________ 
 
 
Investigator’s Signature 
 
 
           Date 
 
 
 
 
 
 
 
 
 

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DOCUMENT HISTORY 
 
VERSION 
DATE 
DESCRIPTION 
1.0 
03 Aug 2018 
   Initial release 
2.0 
17 Jan 2019 
 6.4: Clarification that participants may change the secondary dressing 
on their own, outside of the clinic 
 6.6: Minor clarification on measurements performed at Final Visit 
 7.7: Updated title for Kara Cassady 
 9.1: Listing PI only for simplicity. Other staff members listed on IRB 
 9.2: Clarify clinical monitoring frequency 
 9.3: Clarify linking file for subjects and IDs is paper based and stored 
in a locked cabinet 
 11.2.1: Pre-screening form edited to reflect two visits per week 
 11.2.2: Screening form 
o Added inclusion question on necrotic tissue to match inclusion 
criteria in 5.1 
o Wording adjustment to question 2 to reflect it is an exclusion 
criteria 
o Minor adjustment at end of screening form to capture the above 
adjustments 
 11.3.2: “Form completed by” section added 
 11.3.4: “Form completed by” section added and space to note any 
secondary dressing changes completed at home 
 11.5: Birthdate and subject initials removed from SAE form for 
confidentiality  
 
 
 
 
 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
 
Title: 
A prospective case series evaluating a fibrillar collagen powder 
dressing to treat chronic, stalled lower-extremity wounds  
 
 
Study Description: 
Chronic wounds are a source of significant morbidity and escalating 
healthcare costs. The wound care professional has a myriad of 
modern wound dressings to choose from when treating a wound, 
each of which has benefits and drawbacks. An understanding of how 
a given dressing performs in healing a particular wound is crucial in 
order to determine a clinical mapping of wound dressings to wound 
types; such a categorization would lead to more efficient clinical 
decision making and better patient outcomes. This case series will 
evaluate the ability of a fibrillar collagen powder to improve healing 
of chronic, stalled, lower-extremity wounds. 
 
Objectives: 
 
Evaluate the ability of a fibrillar collagen powder dressing to treat 
chronic, stalled, lower-extremity wounds 
 
 
 
 
Endpoints: 
Primary: Change in wound size over twelve week period 
Secondary: 1) Change in Bates-Jensen Wound Assessment Tool 
score, 2) Change in reported pain level  
 
Study Population: 
Twenty adult patients with chronic lower-extremity wounds (i.e. 
below the knee) of greater than four weeks that have failed to 
respond to at least one advanced wound dressing treatment. 
Specific wound types include: pressure ulcers, diabetic ulcers, and 
venous leg ulcers.  
 
Phase: 
Post-Market 
 
Description of 
Sites/Facilities 
Enrolling 
Participants: 
 
Outpatient podiatry clinics in the United States 
Description of Study 
Intervention: 
Patients who meet the inclusion criteria will be provided with 
fibrillar collagen powder dressing (Puracol® Ultra Powder by 
Medline Industries, Inc.). The powder dressing will be used in 

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accordance with its label. After cleansing the wound by the clinical 
site staff, the powder is placed directly on the wound, and then the 
wound will be covered with an appropriate moisture retentive 
secondary dressing. Patients will visit the clinic twice a week to have 
the powder re-applied. Wound evaluations will take place once a 
week at the outpatient clinic, with the intervention lasting up to 
twelve weeks. Concurrent standard of care, such as compression for 
venous ulcers, will be provided. 
 
Study Duration: 
Total time for study completion to allow accrual of all subjects, and 
appropriate treatment as per the protocol,  will be approximately 
12-18 months 
 
Participant Duration: Participant duration in the study will be a maximum of twelve 
weeks. In the event a participant’s wound completely heals prior to 
the end of twelve weeks, his or her participation in the study will be 
complete at the time of complete wound healing. 
 
 
 
 
 
 
 
 
 

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1.2. Schedule of Activities (SOA) 
REQUIRED 
ASSESSMENTS 
PRE-
SCREENING 
Day -1 
SCREENING 
VISIT 
Day 0 
 (May be combined 
with Initial Visit, 
Day 1) 
INITIAL 
VISIT  
Day 1 
 
DRESSING 
CHANGE 
VISITS 
Twice weekly  
(Every 3 days 
± 1 day) 
 
 
WOUND 
ASSESSMENT 
VISITS 
Once Weekly 
 (Every 7 days ± 
2 days. Will be 
combined with 
Dressing Change 
Visit) 
FINAL VISIT 
12 weeks from 
Initial Visit3 
Pre-Screening 
Questionnaire 1 
X  
 
 
 
 
 
 
Informed Consent 
 
X 
 
 
 
 
Screening Form to assess 
eligibility 
 
X 
 
 
 
 
Decision on eligibility 
 
X 
 
 
 
 
 
 
 
Demographics 
 
 
X 
 
 
 
Wound History 
 
 
X 
 
 
 
Wound Photograph 
 
 
X 
 
X 
X 
Bates-Jensen Wound 
Assessment 
 
 
X 
 
X 
X 
Current Pain Rating 
 
 
X 
 
X 
 
Application of Puracol® 
Ultra 
 
 
X 
X 
X2 
 
Pain Rating  for dressing 
change 
 
 
X 
 
X 
X 
Secondary Dressing 
Notation 
 
 
X 
X 
X2 
 
Adverse Event 
Assessment 
 
X 
X 
X 
X 
X 
 
 
 
1 For participants contacting the research facility 
2 If combined with Dressing Change Visit 
3 Final Visit may occur earlier in the event the participant’s wound has completely healed before 12 
weeks. 

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2. INTRODUCTION  
2.1. Background & Rationale 
Chronic wounds, defined as damage to epidermal or dermal structures present for greater than four 
weeks without significant clinical improvement in spite of appropriate clinical management, 
represent a substantial burden on the healthcare system. Costs for venous leg ulcers, a wound type 
that often becomes chronic, were estimated at $3 billion annually as of 2006.1 Other wound types, 
such as pressure ulcers and diabetic ulcers can also turn into chronic wounds, adding to healthcare 
costs and negatively impacting quality of life. These types of wounds frequently occur in the lower 
extremities due to venous or arterial insufficiency and pressure exerted on the foot or leg.  
A key factor in wound healing is the production, deposition, and integration of collagen in the 
wound bed. Collagen is the most abundant protein in the human body, and it plays a key role in all 
phases of wound healing.2 In chronic wounds, the deposition of de novo collagen is delayed and/or 
altered.3,4  In these wounds there is both a reduction of collagen deposition, coupled with increased 
breakdown of the collagen that does get deposited, that prevents it from integrating into the wound 
bed and healing the wound.  
In an effort to augment the formation and integration of collagen into the wound bed, healthcare 
professionals often turn to collagen based dressings. These dressings are composed of bovine, 
porcine, or avian collagen; the dressings are often in the form of a sheet that can be applied directly 
to the wound or a powder that is sprinkled over the wound. The influx of collagen aids in addressing 
the microenvironment of the wound, which may provide a different mechanism of action for healing 
compared to other advanced wound treatments, which often address the macro environment (e.g. 
moisture retentive dressings). Due to this, collagen dressings may be particularly useful for chronic 
wounds that have not responded to other advanced wound treatments, such as silver sulfadiazine, 
calcium alginate, or hydrocolloid dressings. Indeed, a case series of twenty patients with chronic, 
stalled wounds demonstrated the ability of a bovine-based collagen dressing to advance the healing 
of these wounds.2 In the current study, a novel, porcine-based powder dressing will be evaluated in 
order to determine if it can achieve similar ends.  
2.2. Investigational Product 
Puracol® Ultra Powder collagen wound dressing is a powder-like fibrillar collagen microsponge 
composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in 
the United States, indicated for the management of full and partial thickness wounds: pressure 
ulcers, diabetic ulcers caused by mixed vascular origin, venous ulcers, and several other wound 
types. Appendix 11.1.1 provides the label and instructions for use (IFU) for the device.   
As Puracol® Ultra comes in powder form, a secondary dressing applied over the wound is necessary. 
An appropriate sized dressing from the Optifoam® Gentle silicone border series by Medline 
Industries Inc., will be applied. Information pertaining to these dressings is provided in Appendix 
11.1.2. Furthermore, given that the standard of care for patients with venous ulcers entails 
application of a compression dressing, patients with these types of wounds will also receive CoFlex® 

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TLC Two-Layer Compression System dressing; this dressing is currently marketed for the 
management of venous ulcers. More information regarding the CoFlex® TLC Two-Layer Compression 
System dressing is available in Appendix 11.1.3. 
2.3. Risk/Benefit Profile 
2.3.1. Potential Study Risks 
Participants may experience irritation or a reddening due to the dressing. Participants will be 
under the care of a healthcare professional while using the dressing, and he or she will be able 
to intervene appropriately if the dressing causes any irritation or reddening. 
2.3.2. Potential Study Benefits 
Participants may experience a healing of their chronic, stalled wound as a result of the study 
product application.  
2.3.3. Assessment of Potential Risk/Benefit Profile 
The study product will be used in accordance with its currently marketed IFU, and the risks to 
participants are minor. Participants may experience healing of their wound through the 
application of the dressing. Due to this, the risk/benefit profile is favorable.  
3. OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
 
 
 
Evaluate the ability of a fibrillar 
collagen powder dressing to treat 
chronic, stalled, lower-extremity 
wounds.  
Primary 
 
Change in wound size 
 
 
 
A reduction in 
wound size is 
indicative of 
healing 
Secondary 
 
Change in BWAT score 
 
Change in reported pain level  
o General pain level 
o Pain level at dressing 
change 
 
The BWAT is a 
validated tool for 
wound healing 
 
Pain is indicative of 
healing and wound 
status 

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4. STUDY DESIGN 
4.1. Overall Design 
This is a prospective, open-label, case series investigating if a currently marketed collagen dressing 
can result in improved healing of chronic, stalled, lower-extremity wounds. An outpatient podiatry 
clinic will enroll twenty patients with qualifying wounds and monitor wound healing progress over 
the course of twelve weeks.  
4.2. End of Study Definition  
The conclusion of the study for an individual participant will occur at their last Wound Assessment 
Visit, which will be after twelve weeks of participation or when the wound is completely healed, 
whichever comes first. The study will be deemed complete upon issuance of the final Clinical Study 
Report.  
5. STUDY POPULATION  
5.1. Inclusion Criteria 
In order to participate in the study, a participant must meet ALL of the following criteria 
 
Age 18+ 
 
Has one of the following types of wounds below the knee:  
o Diabetic ulcers 
o Pressure ulcers 
o Venous ulcers 
o Ulcers of mixed-vascular origin 
o Traumatic wounds 
o Post-surgical wounds 
 
Wound has been present for at least four weeks 
 
Wound is free of necrotic tissue or debridement practices will take place prior to Initial 
Visit in order to remove necrotic tissue 
 
Wound has failed at least one wound care treatment  
 
Wound size is between 1 and 100 cm2 
 
Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler 
waveform, measured within three months prior to study enrollment. If monophasic on 
exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and 
no worse than mild disease on segmental pressures.  
 
Wound is confirmed as being free of infection and absence of osteomyelitis  
5.2. Exclusion Criteria 
A participant must not meet ANY of the criteria below to participate in the study 
 
Pregnant, planning to become pregnant during the study timeframe, or breast feeding 

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 
Unable or unwilling to receive porcine collagen 
 
Wound is infected or presence of osteomyelitis 
 
Allergy or sensitivity to collagen 
 
Inability, in the opinion of the Investigator to follow protocol requirements, attend 
follow up visits in a timely manner, or otherwise comply with the requirements of the 
protocol 
 
5.3. Strategies for Recruitment and Retention  
The Principal Investigator (PI) maintains a research-dedicated podiatry clinic. The PI will recruit 
potential subjects via advertisement displayed on Cleveland Regional Transit Authority (RTA) buses 
and trains.  Interior cards displaying a short description and information to contact the research site 
will be displayed on interior cards on the bus and/or trains. Recruitment will also be advertised using 
other social media websites such as Facebook. The PI and/or site staff will offer enrollment to 
patients that may meet the inclusion/exclusion criteria.  Participants will be provided with reminder 
notifications and documentation detailing their scheduled visits to the site.  
6. STUDY PROCEDURES AND ASSESSMENTS 
6.1. Day -1 – Pre-screening 
Interested potential participants who contact the research site will undergo a brief pre-screening 
questionnaire via phone to determine initial eligibility. Potential participants will be assigned a 
screening number in order to de-identify the information on the form. The pre-screening form can 
be found in Appendix 11.2.1.  
6.2. Day 0 - Informed Consent and Screening Visit 
6.2.1. Informed Consent 
Upon arrival to the study site, research staff will provide potential participants with a written 
informed consent form (ICF) that has received approval by an institutional review board (IRB) or 
Ethics Committee. The ICF will be written and administered in compliance with Good Clinical 
Practice (GCP) and comply with all elements required by FDA 21 CFR 50.25, International 
Conference on Harmonization (ICH), and state and local regulations. Research staff will answer 
any questions the potential participant has regarding the form. Written consent from the 
participant must be obtained prior to conducting any other research activities. A copy of the 
signed ICF will be offered to each participant.    
6.2.2. Screening 
After obtaining informed consent, research staff will assess eligibility to participate in the study 
using the screening form provided in Appendix 11.2.2. Participants who qualify will be assigned 
a subject number.  In the event the potential subject has not had a measurement to determine 
adequate blood flow in the past three months, the PI or research staff will assess blood flow via 

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a handheld vascular Doppler device. Subjects must meet the Doppler criteria mentioned in 
section 5.1 of this protocol to be included. 
6.3. Day 1 – Initial Visit 
6.3.1. Demographic and Baseline Data Collection 
The PI or research staff will collect the following demographic data and medical information: 
age, gender, race, height, weight, medical diagnoses, wound location, wound type, duration of 
wound, prior treatments, and current medications. These data will be recorded on the Initial 
Visit Case Report Form (CRF), provided in Appendix 11.3.1.  
6.3.2. Photograph of Wound and Wound Size Measurement 
Measurement of wound size will occur via software provided with an acceptable wound camera, 
to be provided by Medline. The PI will take a photograph of the wound with the camera and 
upload the file to a computer with appropriate software. The software will automatically 
calculate the wound size; this will serve as the wound size data point for the Initial Visit. Wound 
size, in cm2 will be recorded on the Wound Photo CRF; a copy of the CRF is provided in Appendix 
11.3.2. 
6.3.3. Pain Assessment 
Participants will verbally rate their perceived pain level twice during the visit. A “current” pain 
level will be captured by asking the participant his/her current pain during the visit; this 
measurement will be obtained at the beginning of the visit. If debridement is to be performed 
during the visit, the “current” pain evaluation will occur prior to debridement. Additionally, a 
pain level during dressing changes will also be acquired. Participants will use a  0-10 Verbal 
Numeric Pain Rating scale, with 0 corresponding to minimal pain and 10 indicating the worst 
pain imaginable, to indicate their pain level. The values will be recorded on the Wound Photo 
CRF.  
6.3.4. Bates-Jensen Wound Assessment Tool 
The PI or research staff will administer the Bates-Jensen Wound Assessment Tool (BWAT) at the 
Initial Visit in order to gain an understanding of the wound characteristics. The instructions for 
use for the BWAT are provided in Section 11.3.3.1, with the actual tool that will serve as the CRF 
in Section 11.3.3.2. In order to convert the BWAT into a tool that is compatible with the 
idiosyncrasies of this study, a few minor changes were made. The field for “Name” was changed 
to “Subject Number.” In addition, a field for “Date” and “Wound Assessment Number” were 
listed for tracking purposes, given the multiple visits that will occur with this study. Also, the 
BWAT contains three columns for scoring, each corresponding to a separate date and 
assessment. In this study there will likely be more than three visits for each subject, so we have 
deleted two of the columns to avoid confusion; a new BWAT CRF will be used for each visit. 
Similarly, the instructions to plot multiple scores on visual scale provided at the bottom of the 
assessment was removed; the score from that visit will be plotted elsewhere, and the trajectory 
of the scores will be analyzed after study completion using data from all visits.  

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6.3.5. Dressing Application 
Following the wound assessment, the Investigator or other clinician on the research staff will 
cleanse the wound using a wound cleansing solution and apply the Puracol® Ultra Powder 
dressing to the wound. A notation as to the type of secondary dressing applied will be noted on 
the Dressing Log CRF (see Appendix 11.3.4).  
6.4. Dressing Change Visit 
Participants will visit the clinic for a dressing change every Tuesday and Friday (± 1 day). Ultimate 
determination of dressing change frequency will reside with the PI. During these visits, participants 
will be assessed for any Adverse Events (AEs) and have their dressing changed. Documentation of 
the dressing change will be captured in the Dressing Log CRF, available in Appendix 11.3.4. 
Participants may change the secondary dressing on their own, without coming into the clinic. 
6.5. Wound Assessment Visit 
One of the dressing change visits will serve as the wound assessment visit as well. Wound 
assessments will take place every 7 days ± 2 days. The assessments conducted at this visit will be 
identical to those described in Sections 6.3.2 to 6.3.4. All events will be documented via the Wound 
Photograph, BWAT, and Dressing Log CRFs.  
6.6. Final Visit 
The Final Visit will take place 12 weeks after participant enrollment; in the event the wound 
completely heals before 12 weeks have passed, the visit where the PI notes complete wound healing 
will serve as the Final Visit. Data collection will follow the same procedures defined in Sections 6.3.2 
to 6.3.4.  
7. ADVERSE EVENTS  
7.1. Definition of Adverse Event 
The FDA definition for an AE will be used in this study: Adverse event means any untoward medical 
occurrence associated with the use of an intervention in humans, whether or not considered 
intervention related.  
 
7.2. Definition of Serious Adverse Event 
The FDA definition of a Serious Adverse Event (SAE) will be used in this study: An AE or suspected 
adverse reaction is considered "serious" if, in the view of either the PI or Sponsor, it results in any of 
the following outcomes:  
 
Death 
 
A life-threatening adverse event 
 
Inpatient hospitalization or prolongation of existing hospitalization  

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 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions or, 
 
A congenital anomaly/birth defect.  
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize 
the participant and may require medical or surgical intervention to prevent one of the outcomes 
listed in this definition. 
7.3. Severity of Adverse Event 
 
 
Mild: Awareness of signs or symptoms, but easily tolerated; are of minor irritant type, 
causing no loss of time from normal activities; symptoms would not require medication or a 
medical evaluation; signs and symptoms are transient. 
 
Moderate: Discomfort severe enough to cause interference with usual activities; requiring 
treatment but not extended hospitalization or intensive care for the subject. 
 
Severe: Incapacitating with inability to do work or usual activities; signs and symptoms may 
be systemic in nature or require medical evaluation and/or treatment; requiring additional 
hospitalization or intensive care (prolonged hospitalization) 
7.4. Relatedness of Adverse Event and Serious Adverse Event 
 
 
Unrelated: This category applies to those adverse events which, after careful consideration, 
are clearly and incontrovertibly due to extraneous causes (disease, environment, etc.) 
 
Possible: This category applies to those adverse events for which, after careful medical 
consideration at the time they are evaluated, a connection with the Investigational Product 
administration appears unlikely but cannot be ruled out with certainty. 
 
Probable: This category applies to those adverse events which, after careful medical 
consideration at the time they are evaluated, are felt with a high degree of certainty to be 
related to the Investigational Product. 
 
Definite: This category applies to those adverse events which, after careful consideration, 
are clearly and incontrovertibly due to the Investigational Product. 
7.5. Expectedness 
The PI will be responsible for determining whether an AE or SAE is expected or unexpected. An AE 
will be considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the study intervention.  
7.6. Adverse Event Reporting 
AEs will be recorded on the Adverse Event form (Appendix 11.4) by the PI. Changes in the severity of 
an AE will be documented to allow an assessment of the duration of the event at each level of 
severity. Changes in severity will necessitate a new CRF to document the new level of severity. AEs 
characterized as intermittent require documentation of onset and duration of each episode. 

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Non-serious AEs are to be reported to the study Sponsor on a weekly basis for review, and reported 
to the IRB per IRB reporting requirements.  
7.7. Serious Adverse Event Reporting 
The study investigator shall complete an SAE Form (Appendix 11.5) and submit to the study Sponsor 
and to the reviewing IRB as soon as possible, but in no event later than 48 hours after the 
investigator first learns of the effect.  The study Sponsor is responsible for conducting an evaluation 
of the SAE and shall report the results of such evaluation to the FDA and to all reviewing IRBs within 
10 working days after the Sponsor first receives notice of the effect. Thereafter, the Sponsor shall 
submit such additional reports concerning the effect as FDA requests. 
 
For questions regarding this process or the event, you may contact your Medline clinical 
designee or the Medline Director of Clinical Operations: 
Name: Kara Cassady 
Phone:  847-643-3809 
E-mail:  kcassady@medline.com 
8. STATISTICAL CONSIDERATIONS 
8.1. Sample Size Determination  
As this is an open-label, observational case series, meant to evaluate clinical use of the study 
product, a formal power analysis was not conducted. Rather, a sample of 20 participants was chosen 
to provide an initial estimate of product performance in a clinical setting. Data from this study may 
be used to perform a power analysis for larger, future trial.  
8.2. Populations for Analyses 
An evaluable dataset will be used to conduct all analyses. Participants who have at least a valid 
wound assessment at their Initial Visit and their Final Visit, and complied with at least 75% of the 
dressing changes, will be included in this dataset.  
8.3. Data Analysis 
8.3.1. Wound Size Analysis 
Descriptive statistics for initial wound size (measured at the Initial Visit) and final wound size 
(measured at Final Visit) will be calculated. These statistics include measures of central tendency 
(e.g. mean, median), variability (e.g. standard deviation). A 95% confidence interval for mean 
wound size change will also be calculated, assuming normality of the data. For exploratory 
purposes, a paired samples t-test will be conducted on wound size at the Initial Visit vs. Final 
Visit to identify any significant differences in wound size over the course of the study; if the data 
are not normally distributed, a non-parametric test will be used. Finally, change in wound size 

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over time, using data from each visit may be modeled, using other variables such as 
demographic and baseline data, to better understand predictors of wound closure.  
8.3.2. BWAT Analysis 
Descriptive statistics for BWAT score from the Initial Visit and the Final Visit will be calculated. 
Measures of central tendency and variability will also be provided, and a paired samples t-test 
conducted on the change in BWAT score from the Initial Visit and Final Visit will be calculated for 
exploratory purposes; non-parametric methods will be used if the data are not normally 
distributed. Further exploration of the data may occur via modeling BWAT score from each visit 
and including other variables such as demographic and baseline data to better understand 
predictors of wound closure.   
8.3.3. Pain Scale Analysis 
Descriptive measures of central tendency and variability will be provided for both pain ratings at 
the Initial Visit and the Final Visit. A 95% confidence interval for mean change in pain ratings will 
also be calculated, assuming normality of the data. For exploratory purposes, paired samples t-
tests will be conducted on both pain ratings at the Initial Visit vs. Final Visit to identify any 
significant differences in pain over the course of the study; if the data are not normally 
distributed, a non-parametric test will be used. Though these data are technically on an ordinal 
scale, the ten-point scale allows for the mean value to be more informative, and for the 
potential of conducting parametric tests. Finally, change in pain over time may also be modeled 
similarly to change in wound size.  
9. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
9.1. Key Roles and Study Governance 
Principal Investigator 
Windy Cole, DPM,  
Cleveland Foot and Ankle Clinic (Affiliated with Kent State University (KSU) 
7000 Euclid Ave., Suite 101   
Cleveland, OH  44103 
216-231-5612 
 
9.2. Clinical Monitoring 
The Clinical Research Associate (CRA) will confirm that the rights and well-being of subjects are 
protected, and that the reported trial data are accurate, complete, and verifiable from source 
documents. Moreover, the CRA will confirm the conduct of the trial by the PI and site is in 
compliance with the protocol, GCP, and regulatory requirements as well as any applicable 
institution or IRB and federal or local processes. Monitoring will occur  every two months during 
the study duration or more or less frequently if: 

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 
The volume or quality of data is large or there is a backlog of review due to 
unexpected issues 
 
This would also include any large volume of CRFs to be reviewed  
 
The site compliance with the protocol or compliance with expected ICH/GCP and 
regulatory requirements is lacking or there are continuing unresolved compliance 
issues 
 
There are unexpected AE/SAE or subject safety concerns noted  
 
There are any unexpected inconsistencies with study product management 
 
There is a request for more frequent monitoring by the site 
 
Any mutually agreeable situation as determined by the sites and Medline  
The frequency of routine monitoring may be increased to a longer interval after three monitoring 
cycles if on-site situations support this change. CRA will discuss this with Medline Associate 
Director or Clinical Manager and will inform the PI prior to implementation.  
Monitoring activities will include subject eligibility, source data review, CRF completion 
verification, product accountability, site continued suitability, PI study oversight, compliance, and 
all general monitoring activities as outlined in FDAs Code of Federal Regulations and ICH/GCP 
guidelines that guide that activity.   
Medline Industries Inc. may, on occasion, contract with external CROs to provide CRA services and 
those CRAs are authorized to act on behalf of Medline Industries, Inc.  
It is expected that the site will be compliant with any institutional SOPs during the execution of 
the protocol and evidence of that compliance should be readily documented and verifiable by the 
CRA.  
The CRA will generate an internal Medline Industries Inc. visit report that will be filed with the 
Medline Industries, Inc. trial master file and will provide the PI a detailed follow-up letter after 
each monitoring visit that will outline the completed monitoring activities as well as any identified 
areas of concern and the expected/applicable corrections needed. Medline Industries Inc., 
reserves the right to perform audit of the study activities – either routine or for-cause – as 
needed, and may also perform clinical monitoring audit as well. 
 
9.3. Regulatory and Ethical Considerations 
9.3.1. Confidentiality and Privacy 
Participant confidentiality and privacy is strictly held in trust by the PI, his or her staff, and the 
Sponsor. This confidentiality is extended to cover testing of biological samples in addition to the 
clinical information relating to participants. Therefore, documentation, data, and all other 
information generated will be held in strict confidence. No information concerning the study or 
the data will be released to any unauthorized third party without prior written approval of the 
Sponsor. All study data and study records will be managed and stored in accordance with the 

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site’s HIPAA compliant policies on data storage and security. All electronic transmission of data 
will adhere to HIPAA Security Rules. 
 
The study monitor, other authorized representatives of the Sponsor, representatives of the IRB 
and regulatory agencies may inspect all documents and records required to be maintained by 
the PI, including but not limited to, medical records (office, clinic, or hospital) and pharmacy 
records for the participants in this study. The clinical study site will permit access to such 
records. 
 
A master list linking subject numbers to patient name and medical record number will be 
maintained in a locked filing cabinet by the PI. The study participant’s contact information will 
be securely stored at each clinical site for internal use during the study. At the end of the study, 
all records will continue to be kept in a secure location for at least a period of two years, or 
longer if dictated by the reviewing IRB, Institutional policies, Sponsor requirements, or ICH/GCP 
and FDA requirements.  The PI will agree to notify Sponsor of any intent to move or destroy 
these documents.  
 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be maintained at the research sites on the CRFs. Copies of the CRFs, which will 
not contain any identifiable information, will be provided to the Sponsor for the purposes of 
data analysis.  The study data entry and study management systems used by clinical sites and by 
Medline Industries, Inc. research staff will be secured and stored in an access controlled locked 
drawer (any paper forms) and password protected (electronic records). At the end of the study, 
all study databases that are not already de-identified will be de-identified and archived at 
Medline Industries, Inc. 
9.3.2. Safety Oversight 
Given that this is a post-market study on a device used in accordance with its labeling, there is 
minimal safety risk to participants. The PI is a doctor of podiatric medicine and trained in 
treating these types of wounds. In the event there any AEs or SAEs, the PI will review them any 
make any necessary safety determinations as needed.  
9.3.3. Data Handling and Record Keeping 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the PI. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents of any kind (electronic, paper, etc.) should be completed in accordance 
with Good Documentation Practices (GDP) to ensure accurate interpretation of data.  CRFs will 
be created for each subject. The CRA will verify the data entered into the CRF with the site 
source regardless of the type of source. The site will be responsible for developing a written 
process that ensures the CRA is able view the source data.    
 

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Data from the CRFs will be entered into an electronic spreadsheet via dual-entry to assure no 
errors. Data will be transferred to and analyzed with SAS for statistical analysis. SAS allows for 
internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Medline Industries, Inc. will be responsible for 
overseeing final data analysis and confirmation of results.  
9.3.4. Study Records Retention  
 
Study documents should be retained until at least two years have elapsed since the formal 
discontinuation of the study intervention or as required by any applicable FDA guidelines or for 
a longer period if required by local regulations. No records will be destroyed without the written 
consent of the Sponsor, if applicable. It is the responsibility of the Sponsor to inform the PI when 
these documents no longer need to be retained. The PI is required to notify Medline if the 
location of the stored documents is changed after it is defined at the time of the Close Out Visit 
at study end.  
9.3.5. Study Discontinuation  
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to the PI, Sponsor, and IRB.  
If the study is prematurely terminated or suspended, the PI will promptly inform the IRB and 
Sponsor and will provide the reason(s) for the termination or suspension.   
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants as 
determined by AE review 
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the Sponsor and/or IRB. 
9.3.6. Study Closeout 
Upon completion of the study, Medline and/or its designees will notify the site of closeout 
related procedures and will coordinate with the site the return of equipment and/or any unused 
product.  Medline CRA will communicate closely with the PI at that time point and will review all 
close out steps and materials. All study data, related study documents, and unused study 
product, will be returned to the Sponsor.  Sponsor will provide the facility with a summary of the 
activities and findings after the final analysis of the data has been completed. The site will also 
notify the IRB that the study has completed. 

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9.3.7. Conflict of Interest Policy 
The independence of this study from any actual or perceived influence is critical. Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, publication 
or any aspect of this trial will be disclosed and managed. 
9.4. Protocol Deviations 
It is the responsibility of the PI and study staff to use continuous vigilance to identify and report 
deviations on a routine basis. All deviations must be addressed in study source documents, and 
reported to Medline Industries, Inc. Protocol deviations must be sent to the reviewing IRB per 
their policies. The site investigator is responsible for knowing and adhering to the reviewing IRB 
requirements 
9.5. Abbreviations and Terms 
AE 
BWAT 
Adverse Event 
Bates-Jensen Wound Assessment Tool 
CFR 
Code of Federal Regulations 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
DPM 
Doctor of Podiatric Medicine 
GCP 
Good Clinical Practice 
GDP 
Good Documentation Practice 
ICH 
International Conference on Harmonization  
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
PI 
Principal Investigator 
 
10. REFERENCES 
1. Bergan JJ, Schmid-Schonbein GW, Coleridge Smith PD, Nicolaides AN, Boisseau MR, Eklof B. 
Mechanisms of disease: chronic venous disease. N Engl J Med. 2006;355:488-98. 
2. Shah SV, Chakravarthy, D. Evaluation of a bovine 100% native collagen for the treatment of 
chronic wounds: A case series. J Wound Ostomy Continence Nurs. 2015 May-Jun;42(3):226-34. 

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3. Herrick SE, Ireland GW, Simon D, McCollum CN, Ferguson MW. Venous ulcer fibroblasts 
compared with normal fibroblasts show differences in collagen but not fibronectin production 
under both normal and hypoxic conditions. J Invest Dermatol. 1996;106:187-93.  
4. Falanga V. Chronic wounds: pathophysiologic and experimental considerations. J Invest 
Dermatol. 1993;100:721-25. 

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11. APPENDIX 
11.1. 
Products used in study 
11.1.1. Investigational Product: Puracol® Ultra Powder Label and Instructions for Use 
 
 
 

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11.1.2. Optifoam® Gentle Silicone Border Dressings 
Optifoam Gentle silicone border dressings are currently marketed dressings indicated for the management of partial and shallow full-thickness wounds. 
The dressings aid in providing a moist wound environment and the absorption of exudate, which aids in wound healing. The silicone adhesive is often 
less traumatic and painful upon removal compared to acrylic based adhesives. The dressings that will be used in this study are available in four sizes: 
1/6” × 2”, 3” × 3”, 4” × 4”, and 6” × 6”.  
 
 

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11.1.3. CoFlex® TLC Two Layer Compression Bandage System 
CoFlex TLC two-layer compression bandage system is a compressive dressing system intended for use to manage venous disease. The first layer of the 
dressing is a soft foam that wicks away moisture, with the second layer composed of a short stretch cohesive material, providing adaptive compression 
levels. The device also comes with a nylon stocking to apply over the completed dressing for patient comfort and ease of movement under clothes and 
on bed sheets. Further information regarding the device can be found below or at https://www.medline.com/product/CoFlex-TLC-Two-Layer-
Compression-System/Multi-Layer-Compression-Systems/Z05-PF11482?question=coflex+tlc&index=P1&indexCount=1 
 

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11.2. 
Screening Forms 
11.2.1. Pre-Screening Form 
Pre-Screening Form 
 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat 
chronic, stalled lower-extremity wounds 
Screening #:  
Criteria 
Age: ___________      
 Between > 18 
Where is your wound located? ______________________________ 
Must be below knee 
How long has the wound been present? _______________________ 
Must be > 4 weeks 
 
Have you tried any therapies to heal the wound? If so, what were they? 
 
 
________________________________________________________ 
Must have tried at least one 
type of advanced wound 
dressing/therapy 
Would you be able to visit the clinic two times a week for up to 12 
weeks? ________________ 
Must answer yes 
 
 
This subject is:   Continuing in the study ☐            Dismissed from the study ☐             
 
If subject is dismissed, please document reason: _______________________________________ 
 
Form completed by: ____________________________________      Date: ________________ 
 
 
 
 
 
 

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11.2.2. Screening Form 
Screening Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat 
chronic, stalled lower-extremity wounds  
Subject #:  __ __ __ __ __ 
Age: _________  
Gender (please check one):                ☐  Male                 ☐ Female 
Yes           No  
Exclusion Criteria 
1. Does the subject have a known sensitivity to collagen? 
☐            ☐ 
2. Is the subject unwilling to apply a porcine based product to the wound? 
☐            ☐ 
3. Does patient have osteomyelitis or an infection in the wound?  
☐            ☐ 
4. Is the subject pregnant, breast feeding, or intending to become pregnant during the 
duration of the study? 
☐            ☐ 
Inclusion Criteria 
5. Is the wound located below the knee? 
☐            ☐ 
6. Is the chronic wound between 1 cm2 to 100 cm2 
☐            ☐ 
7. Is the subject’s wound duration greater than or equal to four weeks? 
☐            ☐ 
8. Is the wound free of necrotic tissue or will the subject undergo debridement to 
remove necrotic tissue prior to treatment with dressing? 
☐            ☐ 
9. Is the wound a pressure ulcer, diabetic foot ulcer, venous ulcer, ulcer of mixed-
vascular origin, post-surgical, or traumatic wound   (circle wound type) 
☐            ☐ 
10. Has the subject tried an advanced wound dressing or therapy to treat the 
      wound without success? If yes, list below: 
 
 _________________________________________________________________ 
☐            ☐ 
11. Biphasic or triphasic Doppler waveform, or Ankle Brachial Index > 0.8 with no 
worse than mild disease on segmental pressures, taken within last 3 months  
☐            ☐ 
 
See back of form to complete. 
 
 

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To qualify for study, subject must be between:  
 > 18 years old 
 Have a “No” response for questions 1-4 
 Have a “Yes” response for questions 5-10 
This subject is:   Continuing in the study ☐            Dismissed from the study ☐             
If subject is dismissed, please document reason: _______________________________________ 
Form completed by: ____________________________________      Date: ________________ 

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11.3. 
Case Report Forms 
11.3.1. Initial Visit Case Report Form 
Initial Visit Case Report Form 
 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat 
chronic, stalled lower-extremity wounds  
Demographic Data 
Subject Number:    
Age: 
Gender: Male   Female  
Height (in):  
Weight (lbs):  
 
Race (may select more than one): Black    White    Asian    Hispanic    Other  
Relevant Medical Diagnoses and Current Medications:  
 
 
 
Wound History 
Wound Type: 
 
Wound Location: 
 
Duration of wound (in months):  
Prior treatments and duration: 
 
 
 
 
 
 
Has mechanical debridement 
been performed? 
Yes     No  
Form Completed by:  
Date:  

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11.3.2. Wound Photo Case Report Form 
Wound Photo Case Report Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat 
chronic, stalled lower-extremity wounds 
Place photograph of the wound below: 
Subject Number: _________   Date: ___________   Wound Assessment Number: _________   
Wound Size: ________ cm2 (enter value obtained from camera software platform) 
Current Pain Rating: _________                        Dressing Change Pain Rating: __________ 
Form Completed by:                                                                                 Date: 

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11.3.3. Bates-Jensen Wound Assessment Tool (BWAT) 
11.3.3.1. BWAT Instructions for use 
 
General Guidelines: 
 
Fill out the attached rating sheet to assess a wound’s status after reading the definitions and methods of assessment described below. 
Evaluate once a week and whenever a change occurs in the wound. Rate according to each item by picking the response that best 
describes the wound and entering that score in the item score column for the appropriate date. When you have rated the wound on all 
items, determine the total score by adding together the 13-item scores. The HIGHER the total score, the more severe the wound status. 
Plot total score on the Wound Status Continuum to  determine progress. If the wound has healed/resolved, score items 1,2,3 and 4 as =0. 
 
Specific Instructions: 
1. 
Size: Use ruler to measure the longest and widest aspect of the wound surface in centimeters; multiply length x width. Score 
as = 0 if wound healed/resolved. 
 
2. 
Depth: Pick the depth, thickness, most appropriate to the wound using these additional descriptions, score as 
0 = 
   if wound healed/resolved: 
1 =        tissues damaged but no break in skin surface. 
2 =        superficial, abrasion, blister or shallow crater. Even with, &/or elevated above skin surface (e.g., hyperplasia). 
3 =        deep crater with or without undermining of adjacent tissue. 4 =        
visualization of tissue layers not possible due to necrosis.   5 =        supporting 
structures include tendon, joint capsule. 
 
3. 
Edges: Score as = 0 if wound healed/resolved. Use this guide: 
 
Indistinct, diffuse 
= 
unable to clearly distinguish wound outline. 
Attached 
= 
even or flush with wound base, no sides or walls present; flat. 
Not attached 
= 
sides or walls are present; floor or base of wound is deeper than edge. 
Rolled under, thickened 
= 
soft to firm and flexible to touch. 
Hyperkeratosis 
= 
callous-like tissue formation around wound & at edges. 
Fibrotic, scarred 
= 
hard, rigid to touch. 
 
4. 
Undermining: Score as = 0 if wound healed/resolved. Assess by inserting a cotton tipped applicator under the wound edge; 
advance it as far as it will go without using undue force; raise the tip of the applicator so it may be seen or felt on the surface of 
the skin; mark the surface with a pen; measure the distance from the mark on the skin to the edge of the wound. Continue 
process around the wound. Then use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-
shaped quadrants to help determine percent of wound involved. 
 
5. 
Necrotic Tissue Type: Pick the type of necrotic tissue that is predominant in the wound according to color, consistency and 
adherence using this guide: 
White/gray non-viable tissue 
= 
may appear prior to wound opening; skin surface is 
white or gray. 
Non-adherent, yellow slough 
= 
thin, mucinous substance; scattered throughout wound 
bed; easily separated from wound tissue. 
Loosely adherent, yellow slough 
= 
thick, stringy, clumps of debris; attached to wound 
tissue. 
Adherent, soft, black eschar 
= 
soggy tissue; strongly attached to tissue in center or 
base of wound. 
Firmly adherent, hard/black eschar 
= 
firm, crusty tissue; strongly attached to wound base and 
edges (like a hard scab). 
© 2001Barbara Bates-Jensen Used with permission

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6. 
Necrotic Tissue Amount: Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-
shaped quadrants to help determine percent of wound involved. 
 
7. 
Exudate Type: Some dressings interact with wound drainage to produce a gel or trap liquid. Before assessing exudate type, 
gently cleanse wound with normal saline or water. Pick the exudate type that is predominant in the wound according to color 
and consistency, using this guide: 
 
Bloody 
= 
thin, bright red 
Serosanguineous 
= 
thin, watery pale red to pink 
Serous 
= 
thin, watery, clear 
Purulent 
= 
thin or thick, opaque tan to yellow or green may have offensive 
odor 
 
8. 
Exudate Amount: Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie- shaped 
quadrants to determine percent of dressing involved with exudate. Use this guide: 
 
None 
= 
wound tissues dry. 
Scant 
= 
wound tissues moist; no measurable exudate. 
Small 
= 
wound tissues wet; moisture evenly distributed in wound; drainage 
involves < 25% dressing. 
Moderate 
= 
wound tissues saturated; drainage may or may not be evenly distributed in 
wound; drainage involves > 25% to < 75% dressing. 
Large 
= 
wound tissues bathed in fluid; drainage freely expressed; may or may not 
be evenly distributed in wound; drainage involves > 75% of dressing. 
 
9. 
Skin Color Surrounding Wound: Assess tissues within 4cm of wound edge. Dark-skinned persons show the colors "bright 
red" and "dark red" as a deepening of normal ethnic skin color or a purple hue. As healing occurs in dark-skinned persons, the 
new skin is pink and may never darken. 
 
10. 
Peripheral Tissue Edema & Induration: Assess tissues within 4cm of wound edge. Non-pitting edema appears as skin 
that is shiny and taut. Identify pitting edema by firmly pressing a finger down into the tissues and waiting for 5 seconds, on 
release of pressure, tissues fail to resume previous position and an indentation appears. Induration is abnormal firmness of 
tissues with margins. Assess by gently pinching the tissues. Induration results in an inability to pinch the tissues. Use a 
transparent metric measuring guide to determine how far edema or induration extends beyond wound. 
 
11. 
Granulation Tissue: Granulation tissue is the growth of small blood vessels and connective tissue to fill in full thickness 
wounds. Tissue is healthy when bright, beefy red, shiny and granular with a velvety appearance. Poor vascular supply appears 
as pale pink or blanched to dull, dusky red color. 
 
12. 
Epithelialization: Epithelialization is the process of epidermal resurfacing and appears as pink or red skin. In partial thickness 
wounds it can occur throughout the wound bed as well as from the wound edges. In full thickness wounds it occurs from the 
edges only. Use a transparent metric measuring guide with concentric circles divided into 4 (25%) pie-shaped quadrants to 
help determine percent of wound involved and to measure the distance the epithelial tissue extends into the wound. 
 
©2001 Barbara Bates-Jensen Used with permission 
 
 
 
 
 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
35 
 
11.3.3.2. BWAT Case Report Form 
 
Subject Number: ___________               Date:___________          Assessment Number: __________ 
 
Complete the rating sheet to assess wound status. Evaluate each item by picking the response that best describes the wound and 
entering the score in the item score column for the appropriate date. If the wound has healed/resolved, score items 1,2,3, & 4 as =0. 
Location: Anatomic site. Circle, identify right (R) or left (L) and use "X" to mark site on body diagrams: 
 
         
Sacrum & coccyx 
         
Lateral ankle 
         
Trochanter 
         
Medial ankle 
         
Ischial tuberosity 
         
Heel 
         
Buttock 
         
Other site:                                         . 
Shape: Overall wound pattern; assess by observing perimeter and depth.  
 
Circle and date appropriate description: 
         
Irregular 
         
Linear or elongated 
         
Round/oval 
         
Bowl/boat 
         
Square/rectangle          
Butterfly              Other Shape 
 
Item 
Assessment 
Date 
Score 
1. Size* 
*0 = Healed, resolved wound 
1 = Length x width <4 sq cm 
2 = Length x width 4--<16 sq cm 
3 = Length x width 16.1--<36 sq cm  
4 = Length x width 36.1--<80 sq cm  
5 = Length x width >80 sq cm 
2. Depth* 
*0 = Healed, resolved wound 
1 = Non-blanchable erythema on intact skin 
2 = Partial thickness skin loss involving epidermis &/or dermis 
3 = Full thickness skin loss involving damage or necrosis of subcutaneous 
tissue; may extend down to but not through underlying fascia; &/or 
mixed partial & full thickness &/or tissue layers obscured by granulation 
tissue   
4 = Obscured by necrosis 
5 = Full thickness skin loss with extensive destruction, tissue necrosis or 
damage to muscle, bone or supporting structures 
3. Edges* 
*0 = Healed, resolved wound 
1 = Indistinct, diffuse, none clearly visible 
2 = Distinct, outline clearly visible, attached, even with wound base 3 = 
Well-defined, not attached to wound base 
4 = Well-defined, not attached to base, rolled under, thickened  
5 = Well-defined, fibrotic, scarred or hyperkeratotic 
4. Under- mining* 
*0 = Healed, resolved wound 
1 = None present 
2 =Undermining < 2 cm in any area 
3 = Undermining 2-4 cm involving < 50% wound margins  
4 = Undermining 2-4 cm involving > 50% wound margins  
5 = Undermining > 4 cm or Tunneling in any area 
5. Necrotic Tissue 
Type 
1 = None visible 
2 = White/grey non-viable tissue &/or non-adherent yellow slough 
3 = Loosely adherent yellow slough 
4 = Adherent, soft, black eschar 
5 = Firmly adherent, hard, black eschar 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
36 
 
6. Necrotic Tissue 
Amount 
1 = None visible 
2 = < 25% of wound bed covered  
3 = 25% to 50% of wound covered 
4 = > 50% and < 75% of wound covered  
5 = 75% to 100% of wound covered 
7. Exudate Type  
1 = None 
2 = Bloody 
3 = Serosanguineous: thin, water, pale red/pink 
4 = Serous: think, watery, clear 
5 = Purulent: thin or thick, opaque, tan/yellow, with or without odor 
8. Exudate Amount 
1 = None, dry wound 
2 = Scant, wound moist but no observable exudate 
3 = Small 
4 = Moderate 
5 = Large 
9. Skin Color 
Surrounding 
Wound 
1= Pink or normal for ethnic group 
2 = Bright red &/or blanches to touch 
3 = White or grey pallor or hypopigmented 
4 = Dark red or purple &/or non-blanchable 
5 = Black or hyperpigmented 
10. Peripheral Tissue 
Edema 
1 = No swelling or edema 
2 = Non-pitting edema extends < 4cm around wound 
3 = Non-pitting edema extends ≥ 4cm around wound 
4 = Pitting edema extends < 4cm around wound 
5 = Pitting edema extends ≥ 4cm around wound 
11. Peripheral Tissue 
Induration 
1 = None present 
2 = Induration < 2cm around wound 
3 = Induration 2-4cm extending <50% around wound 
4 = Induration 2-4cm extending ≥50% around wound 
5 = Induration > 4cm in any area around wound 
12. Granulation 
Tissue 
1 = Skin intact or partial thickness wound 
2 = Bright, beefy red; 75% to 100% of wound filled &/or tissue overgrowth 
3 = Bright, beefy red; <75% & >25% of wound filled 
4 = Pink, &/or dull, dusky red &/or fills ≤25% of wound 
5 = No granulation tissue present  
13. Epithelialization 
1 = 100% wound covered, surface intact 
2 = 75% to < 100% wound covered &/or epithelial tissue extends > 0.5cm 
into wound bed 
3= 50% to < 75% wound covered &/or epithelial tissue extends < 0.5cm 
into wound bed 
4 = 25% to < 50% wound covered 
5 = < 25% wound covered 
 Total Score 
 Signature 
 
Plot the total score on the Wound Status Continuum by putting an "X" on the line and the date beneath the line.   
©2001Barbara Bates-Jensen     Used with permission

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
37 
 
11.3.4. Dressing Log Case Report Form 
Dressing Log Case Report Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat chronic, stalled lower-extremity 
wounds  
Subject Number:    
Change #1 Date:  
Secondary Dressing(s) Applied:                           
Number secondary dressings changed at home:                   Form Completed By: 
Change #2 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #3 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #4 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #5 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #6 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #7 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
38 
 
Dressing Log Case Report Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat chronic, stalled lower-extremity 
wounds  
Change #8 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #9 Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #10 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #11 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #12 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #13 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #14 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #15 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #15 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
39 
 
Dressing Log Case Report Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat chronic, stalled lower-extremity 
wounds  
Change #16 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #17 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #18 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #19 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #20 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #21 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #22 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #23 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #24 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
40 
 
Dressing Log Case Report Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat chronic, stalled lower-extremity 
wounds  
Change #25 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #26 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #27 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #28 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #29 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #30 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #31 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #32 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #33 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
41 
 
Dressing Log Case Report Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat chronic, stalled lower-extremity 
wounds  
Change #33 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #34 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #35 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #36 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #37 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #38 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #39 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #40 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #41 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
42 
 
Dressing Log Case Report Form 
MED-2018-DIV71-018: A case series evaluating a fibrillar collagen powder dressing to treat chronic, stalled lower-extremity 
wounds  
Change #42 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #43 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #44 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #45 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #46 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #47 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
Change #48 
Date:  
Secondary Dressing(s) Applied: 
Number secondary dressings changed at home:                   Form Completed By: 
 
 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
43 
 
11.4. 
Adverse Event Form 
Site/Subject Information 
Study Sponsor: Medline Industries, Inc. 
Protocol Number: MED-2018-DIV71-018 
Site Number: 
Principal Investigator: 
Subject Number: 
 
 
Adverse Event Information 
# 
Adverse Event: 
Start 
Date: 
DD-MMM-
YYYY 
Stop 
Date: 
DD-MMM-
YYYY 
Ongoing: Frequency: Severity: Outcome: IP Lot #: 
Relation-
ship to IP: 
Action 
Taken  
with IP: 
SAE 
Status: 
Comment: 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
 
 
 Expected 
 
 
 Yes 
 
 
 
 
 
 
 Yes* 
 
 Unexpected 
 No 
 No 
Frequency: 
Severity: 
Outcome: 
Relationship to IP: 
Action Taken with IP: 
SAE Status 
1 = Isolated 
2 = Intermittent 
3 = Continuous 
1 = Mild 
2 = Moderate 
3 = Severe 
1 = Resolved, with no sequelae 
2 = Resolved, with sequelae 
3 = Unresolved 
4 = Death 
5 = Unknown 
1 = Not Related 
2 = Possible 
3 = Probable 
4 = Definite 
1 = None 
2 = Modified 
3 = Interrupted 
4 = Discontinued 
Death, life-threatening, 
prolonged hospitalization, 
significant disability/anomaly, 
medical intervention to prevent 
a serious outcome 
*In the event of a Serious Adverse Event, please complete the Serious Adverse Event Report form and  
send to Medline Industries, Inc. within 48 hours of awareness 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
MED-2018-DIV71-018 
 
 
17 Jan 2019 
V2.0 
 
 
44 
 
11.5. 
Serious Adverse Event 
Site Information 
Study Sponsor: Medline Industries Inc. 
Protocol Number: MED-2018-DIV71-018 
Site Number: 
Principal Investigator: 
Site Address: 
Report Type: 
 Initial 
 Follow-up 
 Final 
Form Completed By: 
Title: 
Telephone: 
E-mail: 
 
Serious Adverse Event Information 
Subject Number: 
 
Gender: 
 Male 
 Female 
Investigational Product: 
Event Description: (Please include a detailed description of the event in question, including the results of any 
laboratory/diagnostic imagery testing) 
Site Notification  
of the Event: 
Date Notified: 
Time Notified: 
Method of Notification: 
Event Start/Stop: 
Start Date: 
Stop Date: 
 Ongoing 
Event Qualifiers: 
(Check all that apply) 
 Death 
 Intervention to Prevent Impairment 
 Life-Threatening 
 Disability/Permanent Damage 
 Initial or Prolonged Hospitalization 
 Congenital Anomaly 
 Other: 

Medline Industries, Inc. 
 
 
Fibrillar dressing for treating chronic, stalled wounds  
CONFIDENTIAL 
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Relevant Medical History: 
Concomitant Medication/Device History: (Please include historical information such as medication/device name, 
dosage, frequency, route, start date, etc.) 
Relationship to 
Investigational Product 
(IP): 
 Not Related (event definitely not related to IP, as judged by the Principal Investigator) 
 Possibly Related (event maybe related to IP, as judged by the Principal Investigator) 
 Related (event definitely related to IP, as judged by the Principal Investigator) 
Action Taken with 
Investigational Product: 
 Discontinued- Please Provide Date: 
 Interrupted- Please Provide Date: 
 None 
Comments: 
 
Confirmation of Receipt:  
SECTION TO BE COMPLETED BY MEDLINE INDUSTRIES INC. 
Date Received: 
Time Received: 
Received By: 
Title: