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.
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
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
Parallel
Standard of Care
Procedure/Surgerydebridement, wound dressings, offloading
DermGEN™
Other interventionDecellularized human dermal matrix created from donated human skin
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.
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.)
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.)
Incidence of adverse events.
Number of adverse events observed for each arm divided by participants in each arm, reported as a percentage
Proportion with complete healing at any time point
Number of wounds closed (Complete healing is defined as 100% epithelialization without drainage)at any time divided by the number of participants in each arm reported as a percentage
Time to first-measured complete healing
Time to first-measured complete healing (Complete healing is defined as 100% epithelialization without drainage)
Mean and median reduction in wound area at 8 weeks
Mean and Median reduction in wound area in comparison to Treatment Day 0. Area measured with Silhouette® measurement camera.
Mean and median reduction in wound area at 12 weeks
Mean and Median reduction in wound area in comparison to Treatment Day 0. Area measured with Silhouette® measurement camera.
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DeCell Technologies Inc.
Lead sponsor
Dalhousie University
Sponsor institution
Canadian Institutes of Health Research (CIHR)
Collaborator
Dalhousie University
Collaborator
Lakehead University
Collaborator
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