Diabetes Mellitus, Diabetic Foot Ulcer, Non-healing Wound, Tissue Injury, Ulcer Foot, Ulcer Healing, Wound; Foot, Wound of Skin
Conditions
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
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.
Interventions
PROCEDUREStandard of Care
debridement, wound dressings, offloading
OTHERDermGEN™
Decellularized human dermal matrix created from donated human skin
Sponsors
Canadian Institutes of Health Research (CIHR)
Dalhousie University
Lakehead University
DeCell Technologies Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masking cannot be accomplished as one intervention will require application of an advanced wound care product (DermGEN™) and the other arm (control) will not receive the intervention. This will be quite obvious to all.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Treatment on Quality of Life (WoundQoL) | 4 weeks | Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks. |
| Proportion with complete healing in the first 12 weeks | 12 weeks | Proportion with complete healing in the first 12 weeks. (Complete healing is defined as 100% epithelialization without drainage.) |
| Incidence of adverse events. | Reports included at any time up to and including 20 weeks post treatment. | Number of adverse events observed for each arm divided by participants in each arm, reported as a percentage |
| Impact of Treatment on Wound - LUMT Score | 1 week | Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks. |
| Mean and median reduction in wound area in the first 4 weeks | 4 weeks | Mean and Median reduction in wound area in comparison to Treatment day 0. Area measured with Silhouette® measurement camera. |
| Proportion with complete healing in the first 8 weeks | 8 weeks | Proportion with complete healing in the first 8 weeks. (Complete healing is defined as 100% epithelialization without drainage.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first-measured complete healing | up to and including 20 weeks post initial treatment (Day 0) | Time to first-measured complete healing (Complete healing is defined as 100% epithelialization without drainage) |
| Mean and median reduction in wound area at 8 weeks | 8 weeks | Mean and Median reduction in wound area in comparison to Treatment Day 0. Area measured with Silhouette® measurement camera. |
| Mean and median reduction in wound area at 12 weeks | 12 weeks | Mean and Median reduction in wound area in comparison to Treatment Day 0. Area measured with Silhouette® measurement camera. |
| Proportion with complete healing at any time point | up to and including 20 weeks post initial treatment (Day 0) | Number of wounds closed (Complete healing is defined as 100% epithelialization without drainage)at any time divided by the number of participants in each arm reported as a percentage |
Countries
Canada
Contacts
Primary ContactIdevania Costa, RN, NSWOC (S), Ph.D
Backup ContactJoanne Ogden, RN,NSWOC
Outcome results
None listed