NCT05251480

Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: DeCell Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Ulcer Foot
• Ulcer Healing
• Diabetic Foot Ulcer
• Non-healing Wound
• Wound of Skin
• Wound; Foot
• Tissue Injury

Interventions

Type	Name	Description
PROCEDURE	Standard of Care	debridement, wound dressings, offloading
OTHER	DermGEN™	Decellularized human dermal matrix created from donated human skin

Timeline

• Start date: 2024-12-30
• Primary completion: 2025-12-30
• Completion: 2026-12-01
• First posted: 2022-02-22
• Last updated: 2024-07-03

Locations

1 site across 1 country: Canada