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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

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

Идентификаторы

NCT: NCT05251480 · DermGEN.RCT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗