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

Launched by DECELL TECHNOLOGIES INC. · Feb 19, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the effectiveness of a treatment called DermGEN™ for healing diabetic foot ulcers (DFUs) in First Nations people living in Northwestern Ontario. DFUs are wounds that can develop on the feet of people with diabetes, and they can be difficult to heal. The study aims to see if using DermGEN™, a special type of skin treatment, can improve healing times, enhance patients' quality of life, and lower treatment costs compared to standard care. Participants will be randomly assigned to either receive DermGEN™ or continue with the usual care at a wound care clinic.

To be eligible for this trial, participants must be adults aged between 18 and 75 with stable Type 1 or Type 2 diabetes, and they should have an active DFU that has been present for at least two weeks. Participants will need to be willing to take part in their own care, like keeping the wound dressing dry and wearing a special cast to help with healing. If you or someone you know might be interested in joining this study, it’s important to note that it is not yet recruiting participants, but it could be a valuable option for those facing challenges with diabetic foot ulcers in the future.

Gender

ALL

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