Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People (NCT05251480)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (18 items).
Location: Northwestern Ontario (NWO) Wound Care Centre of Excellence — Emo, Ontario
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Northwestern Ontario (NWO) Wound Care Centre of Excellence — Emo, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.