DeCell Technologies Inc.
Dr. Paul F. Gratzer
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.
Diabetes Mellitus
Ulcer Foot
Ulcer Healing
Diabetic Foot Ulcer
Non-healing Wound
Wound of Skin
Wound; Foot
Tissue Injury
Standard of Care
DermGEN™
NA
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 120 participants |
Masking : | NONE |
Masking Description : | 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. |
Primary Purpose : | TREATMENT |
Official Title : | 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 |
Actual Study Start Date : | 2024-12-30 |
Estimated Primary Completion Date : | 2025-12-30 |
Estimated Study Completion Date : | 2026-12-01 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 80 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Northwestern Ontario (NWO) Wound Care Centre of Excellence
Emo, Ontario, Canada, P0W 1C0