Evaluation of Micro Water Jet Technology and the Progression of Wound Healing: A Prospective Cohort Evaluating the Efficacy of Micro Water Jet Technology in the Debridement and Healing of Chronic Lower Extremity Ulcers
Phase: NA
Conditions: Diabetic Foot Ulcer, Non-healing Wound, Non-Healing Ulcer of Skin, Venous Leg Ulcer, Venous Ulcer
Sponsor: Stephanie Wu

1 
RESEARCH PROPOSAL 
Evaluation of Micro Water Jet Technology and the Progression of Wound Healing: 
A Prospective Cohort Evaluating the Efficacy of Micro Water Jet Technology in the debridement 
and healing of Chronic Lower Extremity Ulcers 
Protocol ID: MDX-DEB-001
Brief Title: Debritom - Micro Water Jet Technology and Wound Healing 
Date: September 30, 2019

 
2 
PROTOCOL SUMMARY 
 
Study Title 
Evaluation of Micro Water Jet Technology and the Progression of Wound Healing: A 
Prospective Cohort Evaluating the Clinical Efficacy of Micro Water Jet Technology in the 
debridement and healing of Chronic Lower Extremity Ulcers. 
 
Indication 
This study will investigate the clinical efficacy of micro water jet technology in the debridement 
and healing of chronic lower extremity ulcers. 
 
Objectives 
The primary objective of the study is to assess the clinical efficacy of micro water jet technology 
in the debridement and healing of chronic lower extremity ulcers in terms of wound size, 
depth/extent, and percent wound reduction and healing.  Additional assessments will include 
evaluating changes in leg rest pain score using a visual analogue scale (VAS); incidence of 
infection, and pain during debridement via the VAS scale as well as patient feedback regarding 
their debridement experience with micro water jet technology.  The exploratory objective is to 
use near-infrared images of the wound (taken SnapshotNIR, a specialized near-infrared camera) for 
the characterization and measurement of tissue oxygenation that could enable correlation of 
wound tissue oxygenation before and after debridement with micro water jet technology. 
 
Study Design 
This is a prospective cohort, single-center, open-label study in subjects with chronic lower 
extremity wounds.  The study will enroll up to 20 subjects.  Subjects will undergo screening 
evaluations to determine eligibility to enroll in the study.  All study subjects will receive micro 
water jet technology debridement as opposed to other debridement methods as part of their 
wound care treatment. The other aspects of subjects wound care protocol will remain unchanged.  
In the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive 
micro water jet debridement on one or all of the ulcers. 
 
Study Population 
Patients, male or female age 18 or older, with uninfected, chronic lower extremity ulcers greater 
than one-month duration that has not adequately responded to conventional ulcer therapy  
 
Length of Study 
Up to 20 weeks, sooner pending wound healing as defined by 100% re-epithelialization. 
 
Study Treatments 
All study subjects will receive micro water jet technology debridement as opposed to traditional 
debridement using instruments or other means of debridement. Other aspects of subjects wound 
care protocol will remain unchanged. 
 
Overview of Efficacy Assessments 
The following efficacy assessments will be performed: 

 
3 
1. The extent and size of ulcers (summation of the products of the long x short axis for all 
ulcers measured in centimeters squared, plus ulcer depth) will be evaluated and 
photographs of ulcers taken during screening and on all clinic visits up to 20 weeks or 
when the ulcer is healed, whichever is sooner. 
2. Leg rest pain score – VAS graded from 0 (pain free) to Grade 10 (maximum pain) during 
screening on again on all clinical visits for up to 20 weeks, sooner pending wound 
healing. 
3. Pain during Debridement score – VAS graded from 0 (pain free) to Grade 10 (maximum 
pain) during on all clinical visits when debridement is performed for up to 20 weeks, 
sooner pending wound healing. 
4. Subjects feedback regarding their debridement experience with micro water jet 
technology will be collected on all clinical visits when debridement is performed. 
5. Incidence of wound infection. 
 
The following exploratory assessments may be performed pending availability of near-infrared 
image camera: 
1. Near-infrared image of the wound before and after debridement. 
 
Data and Safety Monitoring Plan 
We plan to use the NIDDK 'Data & Safety Monitoring (DSM) Guidelines for Clinical Trials'.  
The PI will evaluate the data on an ongoing basis and quarterly reports will be prepared to 
evaluate the progress of the trial (accuracy of data, verifying consent of subjects, and adherence 
to protocol schedule.).  Clinical and patient data will be maintained, segregated and secured in 
locked filing cabinets only accessible to the Investigators.  Patient records will be held as strictly 
confidential and names, or other identification, will not be used for publication or other purposes.  
All employees related to this proposal will be certified in accord with the NIH Human 
Participants Protection Education for Research Teams. 
 
Sample Size Estimation:  
Previous work done suggests that a small case series of 16 patients is adequate as a pilot trial. 
Accounting for a 20% potential fall out rate means that a total of 20 subjects should be enrolled 
into the study. 
 
Data Analysis 
Data analysis will include descriptive statistics and Chi-square and Fisher’s exact tests for 
categorical variables. Continuous variable will be assessed using the Student t test, and where 
possible linear regression models. Outcomes variables will be compared with repeated measures 
of analysis of variance tests.  Statistical significance will be accepted for p values <.05.  
 

 
4 
TABLE OF CONTENTS 
 
 
TITLE PAGE……………………………………………………………………………………...1 
PROTOCOL SUMMARY………………………………………………………………………...2 
1.  
INTRODUCTION………………………………………………………………………...6 
2. 
STUDY OBJECTIVE……………………………………………………………………..8 
2.1 
Primary Objective…………………………………………………………………………8 
2.2 
Exploratory Objective……………………………………………………………………..8 
3. 
STUDY ENDPOINTS…………………………………………………………………….9 
3.1 
Primary Endpoints………………………..…………………………………………….…9  
3.2 
Exploratory Endpoint……………………………………………………………………...9 
4. 
OVERALL STUDY DESIGN…………………...………………………………………11 
4.1 
Study design……………………………………………………………………...………11 
4.2 
Study duration……………………………………………………………………………11 
5.0 
STUDY PROCEDURE………………………………………………………………….12 
5.1 
Recruitment………………………………………………………………………………12 
5.2 
Informed Consent……………………………………………………………...…………12 
5.3 
Study Participants………………………………………..………………………………12 
5.4 
Subject Events Following Entry…………………………………………………………12 
5.5 
Treatment……………………………………………………….…………………..……14 
5.6 
Subsequent Visits…………………………………….…………………………………..15 
5.7 
End of Study Visit………………………………………………………………………..15 
5.8 
Adjunctive Care……………………………………………………………………….…15 
5.9 
Cost/Compensation to Participants………………………………………………………15 
6.0 
SAFETY…………………………………………………………………………………16 
6.1 
General Protection……………………………………………………………………….16 

 
5 
6.2 
Intrim Visits…………………………………………………………………………...…16 
6.3 
Potential Risks…………………………………………………………………………...16 
7.0 
DATA HANDLING AND RECORDKEEPING.. ……………………………………...17 
7.1 
Data Safety and Monitoring Plan………………………………………….…………….17 
7.2 
Patient Confidentiality……………………………………………………..…………….17 
7.3 
Ethics…………………………………………………………………………………….17 
8.0 
STATISTICAL ANALYSIS…………….............………………………………………18 
8.1 
Sample size estimation…………………………………………………………………..18 
8.2 
Data analysis……………………………………………………………………………..18 
9.0 
REFERENCES………………………………………………………………………..…19 
 

 
6 
1. 
INTRODUCTION 
Chronic ulcerations are wounds that have failed to properly proceed through the repair process 
and do not produce functional or anatomic integrity within a three month healing period.1 The 
underlying causes of chronic wounds often include venous insufficiency, arterial perfusion, 
diabetes, 
unrelieved 
pressure 
as 
well 
as 
contributing 
systemic 
factors 
such 
as 
immunosuppression, nutrition and infection. Due to a population of increasing age and weight, 
and the comorbidities of diabetes and venous insufficiency, lower extremity ulcers that are 
vascular and/or diabetic in nature are the most frequently encountered chronic wounds.1,2 The 
prolonged healing process of chronic ulcerations results in both economic loss and an impaired 
quality of life for patients that suffer from such wounds.  Not only does the management of 
chronic wounds drain healthcare resources, but failure to manage could lead to even more 
devastating situations such as sepsis and amputation.3, 4  
 
Debridement is the removal of devitalized or necrotic tissue or foreign bodies from a wound5 and 
is considered by many as the key initial first step in wound healing.  Debridement may aid 
wound healing by removing tissue with the highest bacterial counts, thereby bringing the wound 
into bacterial balance.  Debridement can also activate platelets to release the contents of their 
alpha granules. The released growth factors stimulate the inflammatory response that is believed 
to play an important role in wound healing.  Optimum debridement should achieve a balance 
between the removal of necrotic tissue and preservation of healthy tissue and not inhibit 
subsequent healing6.  Formation of new granulation tissue following debridement may help to 
perpetuate the wound-healing cascade 
 
Efficient debridement is an essential step in acute and chronic wound management. Chronic 
wounds are likely to require ongoing maintenance debridement rather than a single intervention7. 
The underlying pathogenic abnormalities in chronic wounds cause a continual build-up of 
necrotic tissue, and regular debridement is necessary to reduce the necrotic burden and achieve 
healthy granulation tissue. Debridement also reduces wound contamination and therefore assists 
in reducing tissue destruction8. Dead spaces that may otherwise harbor bacterial growth must be 
exposed during debridement. Various methods of debridement are available, each with its own 
advantages and limitations. The methods that are most efficient at removal of debris may, at the 
same time, be the most detrimental to fragile new growth, and in many cases, more than one 
method may be appropriate. 
 
Hydrosurgery has been shown to be an efficient method of wound debridement and wound bed 
preparation9.  The technology has been shown to be faster, more precise, and results in less tissue 
damage than other debridement methods10.  Debritom+ (Medaxis AG, Baar Switzerland) is a 
hydrosurgery device that utilizes micro water jet technology that has been designed to debride 
acute and chronic wounds precisely and in a tissue-preserving manner. The system has a 510(k) 
approval by the FDA and a CE mark in Europe.  With this technology, the water jet is fed with 
pressure through a tube connected to the main device to a non-return nozzle that generates a very 
fine water jet (Figure 1). The pressure that has been set is equal to the pressure prevailing before 
the point of entry into the nozzle.  A recently published study found the micro water jet to help 
remove fibrin, necrotic tissue, and foreign bodies while leaving the granulating tissue unharmed 
allowing for faster wound healing in chronic, stalled wound11.  The authors noted that 
debridement using micro water jet technology can be carried out with no or only minimal pain, 

 
7 
easily eliminated by simple local measures. Furthermore, the micro water jet application removes 
the need to touch the wound during debridement to minimize possible cross-contamination. 
 
Figure 1. Micro water jet debridement device.  
 

 
8 
2. 
STUDY OBJECTIVES 
2.1 
Primary Objective 
The primary objective of this prospective cohort study is to assess the clinical effectiveness of 
micro water jet technology in the debridement and healing of chronic wounds in terms of wound 
size, depth/extent, and percent wound reduction and healing.  Additional assessments will 
include evaluating changes in leg rest pain score using a visual analogue scale (VAS); incidence 
of infection, and pain during debridement via the VAS scale as well as patient feedback 
regarding their debridement experience with micro water jet technology.   
 
2.2 
Exploratory Objective 
The exploratory objective is to use near-infrared images of the wound (taken via SnapshotNIR, a 
specialized near-infrared camera) for the characterization and measurement of tissue oxygenation 
that could enable correlation of wound tissue oxygenation before and after debridement with 
micro water jet technology (Section 3.2).  Data from the exploratory objective may not be 
included in the clinical study report. 
 

 
9 
3. 
STUDY END POINTS 
 
3.1 
Primary Endpoints 
The primary endpoints are to explore clinical efficacy and include: 
1. The extent and size of ulcers (summation of the products of the long x short axis for all 
ulcers measured in centimeters squared, plus ulcer depth) will be evaluated and 
photographs of ulcers taken during screening and on all clinic visits up to 20 weeks or 
when the ulcer is healed, whichever is sooner. 
2. Leg rest pain score – visual analogue scale (VAS) graded from 0 (pain free) to Grade 10 
(maximum pain) during screening and on all clinic visits up to 20 weeks, or when the 
ulcer is healed, whichever is sooner. 
3. Pain during Debridement score – VAS graded from 0 (pain free) to Grade 10 (maximum 
pain) during on all clinical visits when debridement is performed for up to 20 weeks, 
sooner pending wound healing. 
4. Subjects feedback regarding their debridement experience with micro water jet 
technology will be collected on all clinical visits when debridement is performed. 
5. Incidence of wound infection. 
 
3.2 
Exploratory Endpoint 
Near-infrared images of the wound may be taken via the SnapshotNIR camera (Kent Imaging, 
Calgary, Alberta, Canada) before and after debridement pending camera availability.  SnapshotNIR 
is a non-invasive imaging device that utilizes light in the near-infrared spectrum that harmlessly 
passes through the skin and is reflected off of the blood supplying the tissue to provide insight 
into the availability of oxygenated blood in the tissue (Figure 2).  It is intended for use by 
healthcare professionals as a non-invasive tissue oxygenation measurement system that reports 
an approximate value of oxygen saturation, relative oxyhemoglobin level, and relative 
deoxyhemoglobin level in superficial tissue. SnapshotNIR is FDA and Health Canada cleared. 
Figure 2. SnapshotNIR non-invasive imaging device 
 
During the initial feasibility assessment using micro water jet technology for wound 
debridement, near-infrared images of the wound before and after debridement with the micro 
water jet technology were taken with the patient’s consent (Figure 3a-d).  Figure 3a is the pre-
debridement clinical image of the wound after removing the dressing.  Figure 3c is the pre-
debridement near-infrared image of the wound after removing the dressing.  The oxygenation of 
the tissue in the central aspect of the wound was measured to be 79%, and the image depicted a 
small area of oxygenated tissue (darker shade) around the wound.  Figure 3b is a post-
debridement clinical image of the wound.  Figure 3d is the post-debridement near-infrared image 

 
10 
of the wound using micro water jet technology.  The oxygenation of the tissue in the central 
aspect of the wound was measured to be 96% and the area of oxygenated tissue (darker shade) 
around the wound had almost doubled in size.   
 
Figure 3a. Pre-debridement                                     Figure 3b. post-debridement 
 
 
Figure 3c. Pre-debridement tissue oxygenation    Figure 3d. Post-debridement tissue oxygenation 
 
 
The near-infrared wound images are for exploration into the characterization and measurement 
of tissue oxygenation that could enable correlation of wound tissue oxygenation before and after 
debridement with micro water jet technology.  Analysis of the near-infrared wound images will 
include examination of the percentage and extent of tissue oxygenation before and after 
debridement in response to micro water jet technology debridement.   
 
 
 

 
11 
4. 
OVERALL STUDY DESIGN 
 
4.1 
Study Design 
This is a prospective cohort, single-center, open-label study in subjects with chronic lower 
extremity wounds.  The study will enroll up to 20 subjects.  Subjects will undergo screening 
evaluations to determine eligibility to enroll in the study.  All study subjects will receive micro 
water jet technology debridement as opposed to other debridement methods as part of their 
wound care treatment. The other aspects of subjects wound care protocol will remain unchanged.  
In the case of bilateral limb ulcers, or multiple ulcers, subjects will have the option to receive 
micro water jet debridement on one or all of the ulcers. 
Clinical efficacy analyses will include assessment of changes in the extent and size of ulcers, 
percentage healing and rate of healing, leg rest pain score using VAS scale, pain experience 
during debridement using VAS scale, incidence of wound infection (See Section 3). 
Safety assessments, including AE reporting, physical examination, vital sign measurements, 
concomitant medications will be performed at all clinical visits throughout the study. 
 
4.2 
Study Duration 
Up to 20 weeks, sooner pending wound healing as defined by 100% re-epithelialization. 
 
 

 
12 
5.  
STUDY PROCEDURE 
 
5.1 
Recruitment 
Patients will be recruited by the study investigators and by research coordinators at the Rosalind 
Franklin Health Clinic.  Patients will be invited to participate and the investigator or research 
staff will discuss the study design, duration and risks of participating in the study. The subject 
will then be provided with a consent form to read at their leisure. The investigator or research 
coordinator will be available to answer questions and provide more explanation as requested by 
the potential study subject and their family.  
 
5.2 
Informed Consent 
Informed consent will be obtained by the study coordinator prior to any screening measures.  
Discussion of the study will be done in a private room.  The subject will be allowed to read the 
consent at their leisure and discuss it with family members before they make a decision.  If the 
patient agrees to participate, we will provide them with a copy of the consent, a copy will be 
placed in the medical record and a copy will be placed in the patient’s study folder.   
 
5.3 
Study Participants 
20 patients with chronic lower extremity ulcers will be recruited for this prospective cohort at the 
Rosalind Franklin Health Clinic to receive micro water jet technology debridement as part of 
their wound care treatment plan after being informed of the study and providing informed 
consent.  
Inclusion Criteria and Population: 
a) Male or female age 18 or older 
b) The ability and willingness to provide Informed consent 
c) Presence of a chronic lower extremity ulcer  
 
Chronic ulcer is defined as that ≥ 4 weeks in duration. 
 
Subject’s informed consent for participation prior to proceeding with micro water jet 
technology debridement  
d) Patient’s ulcer cannot exhibit any gross clinical signs of infection. 
e) Patient is willing to participate in all procedures and follow up evaluations necessary to 
complete the study. 
f) Patient willing and able to comply with having micro water jet technology debridement 
potentially weekly or biweekly as part of their wound care treatment plan for up to 20 weeks. 
Exclusion Criteria: 
a) Patients with active wound infection, or untreated osteomyelitis 
b) Patients with dementia, or impaired cognitive function 
c) Patients who are unable or unwilling to participate in all procedures and follow up evaluations 
d) Patient has Active Charcot foot  
e) Patient with malignant wounds  
5.4 
Subject events after entry: 
Screening/ Pre-debridement:   
Subjects will be screened to ensure that they meet the inclusion and exclusion criteria.  The study 
will be explained and written informed consent obtained from each patient prior to the initiation 
of screening procedures.   

 
13 
Following the screening, subjects will receive baseline evaluation/assessment as part of the 
general clinic visit and treatment initiation.  Baseline evaluation/ assessment will include 
recording of clinical observations. 
 
Clinical Observations and Recording: 
1. Wound size and appearance:  
Wound dimensions, locations, and characteristics will be documented prior to 
commencement of the study and assessed weekly or biweekly.  Ulcer assessments include 
wound measurement, photographs, proportion of granulation tissue, and dressing changes.   
 
2. Physical exam:  
Physical exam will be conducted, including vascular, dermatological, deformities and range 
of motion, neurological, and infection assessments, as part of a regular wound care visit.  
 
Medical History: A detailed medical history will include: previous history, location and 
duration of previous ulcers, amputation (toe, foot, below knee, above knee), lower extremity 
bypass, lower extremity angioplasty, CABG, cardiac angioplasty, last visit by physician (in 
weeks), and current/past use of special shoes or insoles.   
Neurological Evaluation: The Neurological assessment will consist of Vibratory Perception 
Threshold testing (VPT) using the technique described by Young12, and the 10 gram 
Semmes-Weinstein monofilament using the criteria described by Armstrong and Lavery13. 
The presence of sensory neuropathy will be identified as vibratory perception threshold 
greater than 25 volts or inability to accurately perceive a 10 gram Semmes-Weinstein 
monofilament at 1 or more of 10 test sites on the sole and dorsum of the foot. 
Vascular Assessment: The vascular assessment will consist of palpation of the dorsalis pedis 
and posterior tibial arteries and non-invasive Doppler studies. Ankle Brachial Index (ABI) 
will be performed of both extremities.  
Deformities & Joint Range of Motion: Range of motion of the ankle, subtalar and first 
metatarsophalangeal joint will be assessed using standard landmarks and procedures. We will 
define hallux rigidus as first metatarsophalangeal joint dorsiflexion less than 65 degrees. Toe 
and metatarsophalangeal joint deformities will be defined as present when a rigid, non-
reducible deformity exists.  
Wound Classification: The site investigators will evaluate the wounds. Wounds will be 
classified according to the University of Texas Wound Classification System (Table 1). 
Although this classification system was originally described for diabetic foot ulcers, this the 
only validated wound classification system and will be adapted for the purpose of this 
study.14  
Table 1: The University of Texas Diabetic Wound Classification System14, 15 

 
14 
 
3. Monitoring diabetic control (where appropriate):  
No specific attempts to improve glucose control will be made during the study by the 
investigators.  Glucose control will not be used as an exclusion criterion. We feel that this 
more accurately reflects the diabetic foot ulcer population. Consultations to primary care 
physicians and sub specialist will be provided as needed.  Patients will be encouraged to 
control their diabetes as well as they can and to contact their usual care provider for 
symptomatic hyperglycemia, hypoglycemia or other diabetes-related problems.  Any changes 
in diabetes management will be recorded.  Patients will monitor their diabetes control in their 
usual manner. 
 
4. VAS pain scale:   
Patient’s pain associated with the ulcer will be assessment and documented via the VAS pain 
scale.  Patient’s pain and subjective comments associated with micro water jet technology 
debridement will also be assessed and documented. 
 
5.5 
Treatment 
Following base assessment, the wound will be debrided using micro water jet technology.  An 
initial test of sterile saline will be sprayed onto the patient’s hand so the patient can get a feel for 
the force of the water jet and know what to expect. Topical analgesic (lidocaine) will be 
administered to the wound area prior to debridement as needed.  Micro water jet technology will 
be used to remove all devitalized, necrotic tissue and until extremely fine bleeding develops.  A 
protective shield will be used to prevent spread of the aerosol formed after the stream of sterile 
saline comes into contact with the wound (Figure 4). Both the hand piece delivering the sterile 
saline stream and the protective shield are one-time use disposable items.  Treatment times will 
be dependent on the wound size and level of contamination.  A previously published 
retrospective study noted the treatment duration to be between 1 and 22 minutes utilizing 100-
200mL of sterile saline as rinsing fluid11.  Hemostasis will be controlled via pressure.  
Appropriate wound dressings will then be applied.  Caution will be used in patients with 
uncontrolled hypertension and patients on anticoagulation therapy or acetylsalicylic acid 
medication.  While debridement is not contraindicated in these patients, there may be a higher 
risk of excessive bleeding.  Compression will initially be used to control hemostasis followed by 
an alginate or a hemostyptic agent. 
Grade
0
I
II
III
A
P re  or pos
tul ce ra tive  lesion 
com ple te ly e pi the lializ ed
Supe rfi c ia l w ound, not
 invol ving 
te ndon, c
aps ul e, or bone
Wound pe
ne tra ting t o t e ndon 
or c aps ul e
W ound pe
ne tra ting t o bone
 or 
joint
B
Pre  or pos
tulc era tive  le sion, 
c om ple te ly e pi the lia lize d w ith 
infe ction
Supe rfi c ia l w ound, not
 invol ving 
te ndon, c
a ps ule , or bone
 w ith 
infe c tion
Wound pe
ne tra ting t o t e ndon 
or c a ps ule  with i nfe ction
W ound pe
ne tra ting t o bone
 or 
joi nt w ith i nfe c tion

 
15 
 
5.6 
Subsequent visits 
Patients will return to clinic every one to two weeks (+/- 2 days) as part of their regular wound 
care treatment plan for follow up assessment including wound evaluation and photograph.  
Wounds will be subsequently debrided using micro water jet technology if deemed appropriate 
by the investigators followed by a dry sterile dressing as previously described.  Wound will be 
followed for a total of 20 weeks or when the wound has completely healed, as defined by 100% 
re-epithelialization. 
 
5.7 
End of study visit 
At the end of the 20-week evaluation, patients with open wounds will return to clinic on Day 112 
(+/- 2 days) for the end of study visit.  In cases of complete wound healing or patient withdraw, 
the end of study evaluation will take place at the patient’s last day of study visit and will occur 
prior to Day 112.  The following assessments will occur at the End of study visit: 
1. Wound evaluation and photograph 
2. VAS pain scale 
3. Wound debridement (if applicable) 
A wound dressing, if deemed necessary by the investigator will be applied.  
 
5.8 
Adjunctive Care:  
All patients will receive standard adjunctive therapy for lower extremity ulcerations.  Efforts will 
be made to control any edema by limb elevation, diuretic medication or compression hose, as 
indicated.  Patients will be advised to stay off the affected foot as much as possible, and asked to 
avoid walking, except as absolutely necessary.  Patients will be offered other assistive modalities 
at the time of enrollment (crutches, canes, and walkers) to enhance postural stability. 
 
5.9 
Cost/Compensation to Participants  
There are no anticipated costs to the patient. Wound debridement procedure is reimbursed by 
CMS under CPT code 11042. The micro water jet device and disposable accessories are 
provided by Medaxis AG as part of the study. We do not anticipate any possible injury to the 
patient or other liability that could accrue to the patient under the normal process of care. 
Participant will be paid $50 total for participating in the study. 
Figure 4.  
Debridement of wound using micro water jet technology.  A 
protective shield is used to prevent the spread of the aerosol 
formed after the stream of sterile saline comes into contact with 
the wound. 

 
16 
6.0 
SAFETY 
 
6.1 
General Protection 
Wound care instructions will be reviewed at every visit to ensure patient compliance with the 
study protocol.  Patients will be instructed to inspect the wound at each dressing change and on 
how to detect signs of wound deterioration, and to immediately report these signs to the 
investigator.  If the ulcer worsens, medical treatment as needed, will be initiated by the 
investigators. At each visit the patient will be questioned about potential adverse experiences 
with the response recorded in patient’s chart. This includes exacerbation of existing condition or 
event.  Infection of soft tissue or bone, amputation, need for incision and drainage, iatrogenic 
ulcer formation, or deterioration of the wound will be considered as an adverse event.  The 
patient will also be questioned as to any problems, adverse experiences, or digressions from the 
study procedures and restrictions.  Relevant findings will be noted in the patient’s chart.   
 
6.2 
Interim Visits  
If a subject experiences significant wound deterioration between scheduled study visits, the 
patient will be instructed to telephone the investigator immediately to arrange for an interim 
visit.  Further treatment of the ulcer will be prescribed at the discretion of the investigator.  
Patients may be removed from the study if the situation warrants. 
24 hour “paging system” Subjects will be instructed to call the Rosalind Franklin University 
Health Clinics if they have any questions or concerns. The Rosalind Franklin University Health 
Clinic has an after-hour answering service for patient emergencies where the on-call physician 
for the research group will be alerted of the situation.  If a subject experiences any wound related 
irritation or complications, they will be urged to contact the clinics for an interim visit.  Patients 
may be removed from the study if the situation warrants. 
 
6.3 
Potential Risks 
Potential risks include wound or systemic infection and deterioration of wound.  Any wound 
deterioration, or infection will be addressed with appropriate local and systemic therapy, as 
warranted. Evidence to support the diagnosis of wound deterioration, infection, abscess, or 
osteomyelitis would be considered an adverse event and recorded accordingly. Any cultured 
organism and antibiotic therapy will be recorded.  Infection will be treated with aggressive 
debridement and appropriate systemic antibiotics as required until the infection has resolved. 
Microbiology confirmation will be recorded. Choice of antibiotic therapy is at the investigator’s 
discretion.  A wound culture will also be obtained (via curettage at the ulcer base, after wound 
debridement) if any signs of wound infection exist. 
 
6.4 
Removal of Patients from Therapy or Assessment 
All patients are free to withdraw from participation in this study at any time, for any reason and 
without prejudice.  The Investigator may terminate a patient from the study for administrative 
reasons, or in the Investigator’s opinion, to protect the patient’s best interest.  If a patient is 
withdrawn before completing the study, the reason for withdrawal will be entered into patient’s 
chart and reported accordingly.  Whenever possible and reasonable, the evaluations which were 
to be conducted at the completion of the study should be performed at the time of premature 
discontinuation. 

 
17 
7.0 
DATA HANDLING AND RECORDKEEPING 
 
7.1 
Data and Safety Monitoring Plan 
We plan to use the NIDDK 'Data & Safety Monitoring (DSM) Guidelines for Clinical Trials'.  
Dr. Wu will evaluate the data on an ongoing basis and quarterly reports will be prepared to 
evaluate the progress of the trial (accuracy of data, verifying consent of subjects, and adherence 
to protocol schedule.).  Clinical and patient data will be maintained, segregated and secured in 
locked filing cabinets only accessible to the Investigators.  Patient records will be held as strictly 
confidential and names, or other identification, will not be used for publication or other purposes.  
All employees related to this grant request will be certified in accord with the NIH Human 
Participants Protection Education for Research Teams. 
 
7.2 
Patient Confidentiality 
Upon entering the study each patient will be assigned a sequential number under which all study 
data will be stored.  No personal identification information will be used.  All information 
collected for this study will be secured in a locked office. Only the investigators and other 
members of study, independent ethics committees and inspectors from government regulatory 
agencies will be able to access patient medical records. 
7.3 
Ethics 
This study will be conducted in compliance with the Declaration of Helsinki and its 
amendments, the International Conference on Harmonisation (ICH) principles of Good Clinical 
Practice (GCP) (including archiving of essential study documents) and the applicable regulations 
of the country in which the study is conducted. 
A properly constituted, valid Institutional Review Board (IRB) or Independent Ethics Committee 
(IEC) must review and approve the protocol, the Investigator’s informed consent form (ICF) and 
related patient information and recruitment materials before the start of the study. 
It is the responsibility of the Investigator to ensure that written informed consent is obtained 
from the patient before any activity or procedure is undertaken that is not part of routine care. 
 
 

 
18 
8.0 
STATISTICAL ANALYSIS 
 
8.1 
Sample Size Estimation:  
Previous work done suggests that a small case series of 16 patients is adequate as a pilot trial. 
Accounting for a 20% potential fall out rate means that a total of 20 subjects should be enrolled 
into the study. 
 
8.2 
Data Analysis 
Data analysis will include descriptive statistics and Chi-square and Fisher’s exact tests for 
categorical variables. Continuous variable will be assessed using the Student t test, and where 
possible linear regression models. Outcomes variables will be compared with repeated measures 
of analysis of variance tests.  Statistical significance will be accepted for p values <.05.  
 

 
19 
9.0 
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