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Not yet recruitingNCT05251480Updated Jul 3, 2024

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

An interventional study of Standard of Care and DermGEN™ in Diabetes Mellitus, Ulcer Foot and Ulcer Healing, sponsored by DeCell Technologies Inc.. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by DeCell Technologies Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

This is the only study on the registry with DeCell Technologies Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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™

Interventions

  • ProcedureStandard of Care

    debridement, wound dressings, offloading

  • OtherDermGEN™

    Decellularized human dermal matrix created from donated human skin

    Also known as: Acellular Dermal Matrix

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.)

    Time frame: 8 weeks

  3. 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.)

    Time frame: 12 weeks

  4. Incidence of adverse events.

    Number of adverse events observed for each arm divided by participants in each arm, reported as a percentage

    Time frame: Reports included at any time up to and including 20 weeks post treatment.

  5. 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.

    Time frame: 1 week

  6. 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.

    Time frame: 2 weeks

  7. 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.

    Time frame: 3 weeks

  8. 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.

    Time frame: 4 weeks

  9. 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.

    Time frame: 8 weeks

  10. 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.

    Time frame: 12 weeks

  11. 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.

    Time frame: 20 weeks

  12. 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.

    Time frame: 4 weeks

  13. 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.

    Time frame: 8 weeks

  14. 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.

    Time frame: 12 weeks

  15. 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.

    Time frame: 20 weeks

Secondary outcomes

  1. 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

    Time frame: up to and including 20 weeks post initial treatment (Day 0)

  2. Time to first-measured complete healing

    Time to first-measured complete healing (Complete healing is defined as 100% epithelialization without drainage)

    Time frame: up to and including 20 weeks post initial treatment (Day 0)

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • Northwestern Ontario (NWO) Wound Care Centre of Excellence
    Emo, Ontario P0W 1C0, Canada
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05251480
Lead sponsor
DeCell Technologies Inc.
Collaborators
Canadian Institutes of Health Research (CIHR), Dalhousie University, Lakehead University
Responsible party
Dr. Paul F. Gratzer (Associate Professor, Dalhousie University) — Principal investigator
First posted
Feb 22, 2022
Start date
Dec 30, 2024 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jul 3, 2024

Study contacts

Idevania Costa, RN, NSWOC (S), Ph.D
Contact
igcosta@lakeheadu.ca
647-230-4742
Joanne Ogden, RN,NSWOC
Contact
j.ogden@bellnet.ca
807-486-3407
Paul F Gratzer, Ph.D.
principal investigator · Dalhousie University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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