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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05251480
• Other study ID #: DermGEN.RCT-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 30, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2022
• Source: DeCell Technologies Inc.
• Contact: Idevania Costa, RN, NSWOC (S), Ph.D
• Phone: 647-230-4742
• Email: igcosta[@]lakeheadu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Non-healing Wound
• Tissue Injury
• Ulcer
• Ulcer Foot
• Ulcer Healing
• Wound of Skin
• Wound; Foot
• Wounds and Injuries

Intervention

Procedure:
• Standard of Care
debridement, wound dressings, offloading

Other:
• DermGEN™
Decellularized human dermal matrix created from donated human skin

Locations

Country	Name	City	State
Canada	Northwestern Ontario (NWO) Wound Care Centre of Excellence	Emo	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
DeCell Technologies Inc.	Canadian Institutes of Health Research (CIHR), Dalhousie University, Lakehead University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean and median reduction in wound area in the first 4 weeks	Mean and Median reduction in wound area in comparison to Treatment day 0. Area measured with Silhouette® measurement camera.	4 weeks
Primary	Proportion with complete healing in the first 8 weeks	Proportion with complete healing in the first 8 weeks. (Complete healing is defined as 100% epithelialization without drainage.)	8 weeks
Primary	Proportion with complete healing in the first 12 weeks	Proportion with complete healing in the first 12 weeks. (Complete healing is defined as 100% epithelialization without drainage.)	12 weeks
Primary	Incidence of adverse events.	Number of adverse events observed for each arm divided by participants in each arm, reported as a percentage	Reports included at any time up to and including 20 weeks post treatment.
Primary	Impact of Treatment on Wound - LUMT Score	Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.	1 week
Primary	Impact of Treatment on Wound - LUMT Score	Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.	2 weeks
Primary	Impact of Treatment on Wound - LUMT Score	Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.	3 weeks
Primary	Impact of Treatment on Wound - LUMT Score	Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.	4 weeks
Primary	Impact of Treatment on Wound - LUMT Score	Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.	8 weeks
Primary	Impact of Treatment on Wound - LUMT Score	Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.	12 weeks
Primary	Impact of Treatment on Wound - LUMT Score	Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.	20 weeks
Primary	Impact of Treatment on Quality of Life (WoundQoL)	Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.	4 weeks
Primary	Impact of Treatment on Quality of Life (WoundQoL)	Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.	8 weeks
Primary	Impact of Treatment on Quality of Life (WoundQoL)	Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.	12 weeks
Primary	Impact of Treatment on Quality of Life (WoundQoL)	Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.	20 weeks
Secondary	Proportion with complete healing at any time point	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	up to and including 20 weeks post initial treatment (Day 0)
Secondary	Time to first-measured complete healing	Time to first-measured complete healing (Complete healing is defined as 100% epithelialization without drainage)	up to and including 20 weeks post initial treatment (Day 0)
Secondary	Mean and median reduction in wound area at 8 weeks	Mean and Median reduction in wound area in comparison to Treatment Day 0. Area measured with Silhouette® measurement camera.	8 weeks
Secondary	Mean and median reduction in wound area at 12 weeks	Mean and Median reduction in wound area in comparison to Treatment Day 0. Area measured with Silhouette® measurement camera.	12 weeks

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