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

Official title

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

Overview

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.

Interventions

• Procedure Standard of Care
  debridement, wound dressings, offloading
• Other DermGEN™
  Decellularized human dermal matrix created from donated human skin

Primary outcome measures

• Mean and median reduction in wound area in the first 4 weeks [Time frame: 4 weeks]
• Proportion with complete healing in the first 8 weeks [Time frame: 8 weeks]
• Proportion with complete healing in the first 12 weeks [Time frame: 12 weeks]
• Incidence of adverse events. [Time frame: Reports included at any time up to and including 20 weeks post treatment.]
• Impact of Treatment on Wound - LUMT Score [Time frame: 1 week]
• Impact of Treatment on Wound - LUMT Score [Time frame: 2 weeks]
• Impact of Treatment on Wound - LUMT Score [Time frame: 3 weeks]
• Impact of Treatment on Wound - LUMT Score [Time frame: 4 weeks]
• Impact of Treatment on Wound - LUMT Score [Time frame: 8 weeks]
• Impact of Treatment on Wound - LUMT Score [Time frame: 12 weeks]

Secondary outcome measures (4)

• Proportion with complete healing at any time point [Time frame: up to and including 20 weeks post initial treatment (Day 0)]
• Time to first-measured complete healing [Time frame: up to and including 20 weeks post initial treatment (Day 0)]
• Mean and median reduction in wound area at 8 weeks [Time frame: 8 weeks]
• Mean and median reduction in wound area at 12 weeks [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• Participant and social support (e.g., family, caregiver) ready and willing to participate and comply with follow-up regime
• Participant willing to be involved in self-care (e.g., keep dressing dry at home) required during treatment
• Participant willing to wear Total Contact Cast (TCC) for wound off-loading during treatment
• Participant or legal representative has read and signed the informed consent form
• Documented stable Type I or II diabetes (HbA1C between 5.0 to 10 mmol/L within 1 month prior to Day 0)
• Ulcer has been present for a minimum of 2 weeks as of Day 0
• Ulcer area is ≥2 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 dead tissue and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0
• Adequate perfusion to the extremity determined by at least one of the following:

Palpable pedal pulses, Transcutaneous oxygen measurement at the dorsum of the foot ≥30 mm Hg, Ankle-brachial index ranging from 0.8 to 1.2, At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries

Exclusion criteria

• The individual has any condition that seriously compromises their capacity to provide consent and answers questions related to this study.
• Untreated infection of soft tissue or bone and/or autoimmune connective tissue disorders
• Ulcer is over Charcot deformity (joints deformity of foot and ankle common in people with diabetes)
• Body mass index ≥50 kg/m2
• Ulcer is not classified as diabetes-related
• Ulcer has tunnels or sinus tracts that cannot be completely debrided
• Medical condition(s) that in the investigators' opinion make the patient inappropriate for study (e.g active liver disease)
• Presence of malignant disease not in remission for 5 years or more
• The individual is undergoing chemotherapy/radiation therapy
• The individual received radiation therapy within 30 days of Day 0 of study
• The individual is taking an immunosuppressant medication (e.g., corticosteroids, immunosuppression or cytotoxic agents), or is anticipated to require such agents during study
• Presence of acute or chronic hepatitis, liver disease, anemia, serum albumin <2.0 gm/dL, or has alkaline phosphatase or LDH at twice the normal upper limit
• Obvious clinical signs and symptoms of ongoing tissue infection (i.e., cellulitis) or bone infection (i.e., osteomyelitis)
• Female individuals are pregnant at time or intend to get pregnant during study time
• The individual has known allergies to antibiotics, such as penicillin and streptomycin
• The individual is an active smoker (smoke one or more cigarette a day)
• The individual has a history of a bleeding disorder or is taking blood thinner medication

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Northwestern Ontario (NWO) Wound Care Centre of Excellence — Emo

Identifiers

NCT: NCT05251480 · DermGEN.RCT-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗