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

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetic Ulcer, Diabetic Foot Ulcer, Non-healing Wound, Tissue Engineering, Regenerative Medicine, Decellularized Matrix, Acellular Dermal Matrix, Tissue Allograft, Indigenous Healing, Advanced Wound Care Read More

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