Acellular Dermal Allograft for Chronic Diabetic Wounds

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DermGEN™, which is a special type of skin graft made from human skin that has had its cells removed. The goal is to see if DermGEN™ can help heal diabetic foot ulcers (DFUs) faster. Diabetic foot ulcers are wounds that can be very difficult to heal, often taking 12 to 16 weeks to close completely. This trial aims to find a better solution for these stubborn wounds by using DermGEN™ to improve healing and reduce the time needed for recovery.

To participate in the trial, patients must have a diabetic foot ulcer that has been present for at least two weeks and has not healed by more than 30% in that time. The ulcer must be at least 1 cm² in size and should be free of infection or dead tissue. Patients must also have good blood flow to their feet and agree to follow the study's guidelines. It’s important to note that patients with certain conditions, such as gangrene or those taking specific medications that suppress the immune system, will not be eligible. Participants will receive the new treatment and will be monitored closely to see how well it works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied:
• • 1. Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.
• • 2. Study ulcer has healed \<30% in size during the 2 weeks prior to Day 0.
• • 3. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.
• • 4. Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule.
• • 5. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0.
• • 6. Patient has adequate circulation to the foot as evidenced by toe pressure measurement.
• • 7. Female patients are not pregnant at time of, or during study.
• • 8. Patient and caregiver ready and willing to participate and comply with follow-up regime.
• • 9. Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form.
• Exclusion Criteria:
• A subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied:
• • 1. Evidence of gangrene on affected foot.
• • 2. Ulcer is over Charcot deformity (fractures or dislocation).
• • 3. Ulcer is non-diabetic in etiology.
• • 4. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study.