Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People
1 other identifier
interventional
120
1 country
1
Brief Summary
The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs of treatment of DFUs in First Nations people living in the Northwestern Ontario Communities. First Nations people with active diabetic foot (DFU) ulcer attending a wound care clinic located at the Rainy River district office. An interventional, two-arm, randomized, prospective study of (1) standard of care (control) vs. (2) DermGEN™ - a decellularized dermal matrix (treatment) will be used in the treatment and management of DFU. Patients will be randomized to each arm (n=60 per arm) based on power calculations using data from our Pilot study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Dec 2024
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 22, 2022
CompletedStudy Start
First participant enrolled
December 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJuly 3, 2024
July 1, 2024
1 year
November 3, 2021
July 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
Mean and median reduction in wound area in the first 4 weeks
Mean and Median reduction in wound area in comparison to Treatment day 0. Area measured with Silhouette® measurement camera.
4 weeks
Proportion with complete healing in the first 8 weeks
Proportion with complete healing in the first 8 weeks. (Complete healing is defined as 100% epithelialization without drainage.)
8 weeks
Proportion with complete healing in the first 12 weeks
Proportion with complete healing in the first 12 weeks. (Complete healing is defined as 100% epithelialization without drainage.)
12 weeks
Incidence of adverse events.
Number of adverse events observed for each arm divided by participants in each arm, reported as a percentage
Reports included at any time up to and including 20 weeks post treatment.
Impact of Treatment on Wound - LUMT Score
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
1 week
Impact of Treatment on Wound - LUMT Score
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
2 weeks
Impact of Treatment on Wound - LUMT Score
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
3 weeks
Impact of Treatment on Wound - LUMT Score
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
4 weeks
Impact of Treatment on Wound - LUMT Score
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
8 weeks
Impact of Treatment on Wound - LUMT Score
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
12 weeks
Impact of Treatment on Wound - LUMT Score
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
20 weeks
Impact of Treatment on Quality of Life (WoundQoL)
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
4 weeks
Impact of Treatment on Quality of Life (WoundQoL)
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
8 weeks
Impact of Treatment on Quality of Life (WoundQoL)
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
12 weeks
Impact of Treatment on Quality of Life (WoundQoL)
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
20 weeks
Secondary Outcomes (4)
Proportion with complete healing at any time point
up to and including 20 weeks post initial treatment (Day 0)
Time to first-measured complete healing
up to and including 20 weeks post initial treatment (Day 0)
Mean and median reduction in wound area at 8 weeks
8 weeks
Mean and median reduction in wound area at 12 weeks
12 weeks
Study Arms (2)
Standard of Care
ACTIVE COMPARATORThe standard of care includes physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment
DermGEN™
EXPERIMENTALA decellularized dermal matrix created from donated human skin. This arm will receive the same care as the Standard of Care control arm-physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment-with the addition of DermGEN™ onto the wound at the first visit.
Interventions
Decellularized human dermal matrix created from donated human skin
Eligibility Criteria
You may qualify if:
- Participant and social support (e.g., family, caregiver) ready and willing to participate and comply with follow-up regime
- Participant willing to be involved in self-care (e.g., keep dressing dry at home) required during treatment
- Participant willing to wear Total Contact Cast (TCC) for wound off-loading during treatment
- Participant or legal representative has read and signed the informed consent form
- Documented stable Type I or II diabetes (HbA1C between 5.0 to 10 mmol/L within 1 month prior to Day 0)
- Ulcer has been present for a minimum of 2 weeks as of Day 0
- Ulcer area is ≥2 cm2 prior to debridement at Day 0 of study
- Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule
- Ulcer is free of dead tissue and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0
- Adequate perfusion to the extremity determined by at least one of the following:
- Palpable pedal pulses, Transcutaneous oxygen measurement at the dorsum of the foot ≥30 mm Hg, Ankle-brachial index ranging from 0.8 to 1.2, At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries
You may not qualify if:
- The individual has any condition that seriously compromises their capacity to provide consent and answers questions related to this study.
- Untreated infection of soft tissue or bone and/or autoimmune connective tissue disorders
- Ulcer is over Charcot deformity (joints deformity of foot and ankle common in people with diabetes)
- Body mass index ≥50 kg/m2
- Ulcer is not classified as diabetes-related
- Ulcer has tunnels or sinus tracts that cannot be completely debrided
- Medical condition(s) that in the investigators' opinion make the patient inappropriate for study (e.g active liver disease)
- Presence of malignant disease not in remission for 5 years or more
- The individual is undergoing chemotherapy/radiation therapy
- The individual received radiation therapy within 30 days of Day 0 of study
- The individual is taking an immunosuppressant medication (e.g., corticosteroids, immunosuppression or cytotoxic agents), or is anticipated to require such agents during study
- Presence of acute or chronic hepatitis, liver disease, anemia, serum albumin \<2.0 gm/dL, or has alkaline phosphatase or LDH at twice the normal upper limit
- Obvious clinical signs and symptoms of ongoing tissue infection (i.e., cellulitis) or bone infection (i.e., osteomyelitis)
- Female individuals are pregnant at time or intend to get pregnant during study time
- The individual has known allergies to antibiotics, such as penicillin and streptomycin
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DeCell Technologies Inc.lead
- Canadian Institutes of Health Research (CIHR)collaborator
- Dalhousie Universitycollaborator
- Lakehead Universitycollaborator
Study Sites (1)
Northwestern Ontario (NWO) Wound Care Centre of Excellence
Emo, Ontario, P0W 1C0, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul F Gratzer, Ph.D.
Dalhousie University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Masking cannot be accomplished as one intervention will require application of an advanced wound care product (DermGEN™) and the other arm (control) will not receive the intervention. This will be quite obvious to all.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 3, 2021
First Posted
February 22, 2022
Study Start
December 30, 2024
Primary Completion
December 30, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share