Acellular Dermal Allograft for Chronic Diabetic Wounds
Sponsored by University Health Network, Toronto
About this trial
Last updated 2 years ago
Study ID
23-5933
Status
Not yet recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
18+ Years
All Sexes
Trial Timing
Started 2 years ago
What is this trial about?
The purpose of this study is to determine the efficacy of a novel decellularized dermal matrix (DDM) DermGEN™ for the treatment of diabetic foot ulcers (DFU). Despite several advances in wound treatments, hard-to-heal wounds, such as diabetic foot ulcer, still require 12 to 16 weeks to achieve complete closure. Although the focus of most research into wound-healing treatments has been on moisture and bacterial control, new approaches that target the instability of the extracellular matrix (ECM) in a wound are timely and much needed, particularly for hard-to-heal wounds such as DFUs. Innovative technologies that provide ECM interactions halt the chronic inflammatory cycle and stimulate cells that allow for tissue regeneration and wound healing. DermGEN™ is a human dermal allograft that has been minimally processed from human skin to remove epidermal and dermal cells while preserving the structure and intrinsic properties of the natural extracellular matrix of the dermis. This has potential to facilitate a shorter wound-healing time.
What are the participation requirements?
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.