Status:
NOT_YET_RECRUITING
Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People
Lead Sponsor:
DeCell Technologies Inc.
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Dalhousie University
Conditions:
Diabetes Mellitus
Ulcer Foot
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 peopl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05251480
Start Date
December 30 2024
End Date
December 1 2026
Last Update
July 3 2024
Active Locations (1)
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1
Northwestern Ontario (NWO) Wound Care Centre of Excellence
Emo, Ontario, Canada, P0W 1C0