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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Diabetic Foot Ulcer; Wound; Foot; Wound of Skin; Tissue Injury; Ulcer Foot; Ulcer Healing; Non-healing Wound
• Intervention / Treatment: Procedure: Standard of Care; Other: DermGEN™

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Idevania Costa, RN, NSWOC (S), Ph.D; Phone Number: 647-230-4742; Email: igcosta@lakeheadu.ca
• Study Contact Backup: Name: Joanne Ogden, RN,NSWOC; Phone Number: 807-486-3407; Email: j.ogden@bellnet.ca

Study Locations

• Canada
  • Ontario
    • Emo, Ontario, Canada, P0W 1C0
      • Northwestern Ontario (NWO) Wound Care Centre of Excellence
      • Contact: Joanne Ogden, RN, NSWOC; Phone Number: 214 (807) 486-3407; Email: j.ogden@bellnet.ca
      • Contact: Connie Smith; Phone Number: 212 (807) 486-3407; Email: connie.smith@bellnet.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard of Care; The standard of care includes physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment	Procedure: Standard of Care; debridement, wound dressings, offloading
EXPERIMENTAL: DermGEN™; A decellularized dermal matrix created from donated human skin. This arm will receive the same care as the Standard of Care control arm-physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment-with the addition of DermGEN™ onto the wound at the first visit.	Other: DermGEN™; Decellularized human dermal matrix created from donated human skin; Other Names: Acellular Dermal Matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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

Collaborators and Investigators

• Sponsor: DeCell Technologies Inc.
• Collaborators: Canadian Institutes of Health Research (CIHR); Dalhousie University; Lakehead University
• Investigators: Principal Investigator: Paul F Gratzer, Ph.D., Dalhousie University

Publications and helpful links

Helpful Links

• Site for product description, use

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 30, 2022
• Primary Completion (ANTICIPATED): December 30, 2024
• Study Completion (ANTICIPATED): December 1, 2025

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (ACTUAL): February 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Diabetic Foot Ulcer; Acellular Dermal Matrix; Tissue Engineering; Regenerative Medicine; Non-healing Wound; Diabetic Ulcer; Decellularized Matrix; Tissue Allograft; Indigenous Healing; Advanced Wound Care
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Wounds and Injuries
• Other Study ID Numbers: DermGEN.RCT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No