Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People (NCT05251480)
Examining the Effectiveness of DermGEN™ Versus Standard of Care in the Treatment of Diabetic Foot Ulcers in First Nations People Living in Northwestern Ontario Communities
🩺 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: Review the eligibility criteria below.
Location: Northwestern Ontario (NWO) Wound Care Centre of Excellence — Emo, Ontario
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
- Standard of Care (PROCEDURE)
- DermGEN™ (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Northwestern Ontario (NWO) Wound Care Centre of Excellence — Emo, Ontario
📞 Contact the Study Coordinator
Phone: (647) 230-4742
Email: igcosta@lakeheadu.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
More studies in Diabetes Mellitus
- The REST Study for CGM Use in Older Adults With Insulin-treated Diabetes — Boston, Massachusetts
- Oral Anti Diabetic Agents in the Hospital — Atlanta, Georgia
- Full Plate Living Nutrition Education Program — Madison, Wisconsin
- Evaluation of Arts-Based Storytelling Program in Adolescents With Diabetes — San Francisco, California
- Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes — Cleveland, Ohio
- Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years — Charlestown, Massachusetts
Explore by condition: All Diabetes Mellitus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.