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Skin-based wound matrix DermGEN for diabetic foot ulcers

Tests a donor skin matrix for healing diabetic foot ulcers in adults.

Key facts

Who runs it
University Health Network, Toronto
Where
Canada1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Acellular Dermal Allograft for Chronic Diabetic Wounds
Status
Not yet recruiting
People taking part
30 people, planned
Started
1 Apr 2024
Expected to end
30 Dec 2026
Type of study
Interventional
Treatments tested
  • decellularized dermal matrix
Record updated
29 January 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a diabetic foot ulcer that is healing slowly. They will be treated with DermGEN™, a skin graft made from donated human skin.

Age
18 Years and older
Sex
All
Disease stage
A diabetic foot ulcer present for at least 2 weeks, which healed less than 30% in the 2 weeks before Day 0. It is at least 1 cm2 in size. It goes through the skin into the tissue below, but muscle, tendon, bone or joint capsule are not exposed. It has no dead tissue or infection and is fit to receive a skin graft. Blood flow to the foot must be good enough, measured by toe pressure.
Earlier treatment
People cannot join if they take corticosteroids by mouth or injection, immune-suppressing drugs or cytotoxic drugs, or are expected to need them during the study.

Main reasons for not taking part

  • Gangrene (dead tissue) on the affected foot
  • Ulcer over a Charcot deformity (fractures or dislocation)
  • Ulcer not caused by diabetes
  • Pregnancy at the start of or during the study
  • Taking corticosteroids, immune-suppressing drugs or cytotoxic drugs

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied:
  • Patient's ulcer has been present for a minimum of 2 weeks as of Day 0
  • Study ulcer has healed <30% in size during the 2 weeks prior to Day 0
  • Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study
  • Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule
  • Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0
  • Patient has adequate circulation to the foot as evidenced by toe pressure measurement
  • Female patients are not pregnant at time of, or during study
  • Patient and caregiver ready and willing to participate and comply with follow-up regime
  • Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form

Who cannot take part

  • Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study
  • Ulcer is over Charcot deformity (fractures or dislocation)
  • Ulcer is non-diabetic in etiology
  • A subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied:
  • Evidence of gangrene on affected foot

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • DermgenTreatment being tested

    Application of Dermgen

    Treatment: decellularized dermal matrix

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Acellular Dermal Allograft for Chronic Diabetic Wounds
Plain-language title
Skin-based wound matrix DermGEN for diabetic foot ulcersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
29 January 2024