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

Sponsor
DeCell Technologies Inc.
Study ID
NCT05251480
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Feb 22, 2022
Start date
Dec 30, 2024
Status verified
Jul 2024
Primary completion
Dec 30, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    The standard of care includes physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment
  • Experimental: DermGEN™
    A decellularized dermal matrix created from donated human skin. This arm will receive the same care as the Standard of Care control arm-physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment-with the addition of DermGEN™ onto the wound at the first visit.

Primary Outcome Measure

Mean and median reduction in wound area in the first 4 weeks [ Time Frame: 4 weeks ]

Central Contacts

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