Clinical trial NCT05251480: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Ulcer Foot
Ulcer Healing
Diabetic Foot Ulcer
Non-healing Wound
Wound of Skin
Wound; Foot
Tissue Injury
Keywords: Diabetic Ulcer
Diabetic Foot Ulcer
Non-healing Wound
Tissue Engineering
Regenerative Medicine
Decellularized Matrix
Acellular Dermal Matrix
Tissue Allograft
Indigenous Healing
Advanced Wound Care
Lead sponsor: DeCell Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Dalhousie University
name: Lakehead University
First posted: 2022-02-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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 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.


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

Primary outcomes:
measure: Mean and median reduction in wound area in the first 4 weeks
timeFrame: 4 weeks
measure: Proportion with complete healing in the first 8 weeks
timeFrame: 8 weeks
measure: Proportion with complete healing in the first 12 weeks
timeFrame: 12 weeks
measure: Incidence of adverse events.
timeFrame: Reports included at any time up to and including 20 weeks post treatment.
measure: Impact of Treatment on Wound - LUMT Score
timeFrame: 1 week
measure: Impact of Treatment on Wound - LUMT Score
timeFrame: 2 weeks
measure: Impact of Treatment on Wound - LUMT Score
timeFrame: 3 weeks
measure: Impact of Treatment on Wound - LUMT Score
timeFrame: 4 weeks
measure: Impact of Treatment on Wound - LUMT Score
timeFrame: 8 weeks
measure: Impact of Treatment on Wound - LUMT Score
timeFrame: 12 weeks
measure: Impact of Treatment on Wound - LUMT Score
timeFrame: 20 weeks
measure: Impact of Treatment on Quality of Life (WoundQoL)
timeFrame: 4 weeks
measure: Impact of Treatment on Quality of Life (WoundQoL)
timeFrame: 8 weeks
measure: Impact of Treatment on Quality of Life (WoundQoL)
timeFrame: 12 weeks
measure: Impact of Treatment on Quality of Life (WoundQoL)
timeFrame: 20 weeks
Secondary outcomes:
measure: Proportion with complete healing at any time point
timeFrame: up to and including 20 weeks post initial treatment (Day 0)
measure: Time to first-measured complete healing
timeFrame: up to and including 20 weeks post initial treatment (Day 0)
measure: Mean and median reduction in wound area at 8 weeks
timeFrame: 8 weeks
measure: Mean and median reduction in wound area at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Emo
country: Canada
facility: Northwestern Ontario (NWO) Wound Care Centre of Excellence
state: Ontario
Study officials:
affiliation: Dalhousie University
name: Paul F Gratzer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: