Diabetes MellitusNCT05251480
Examining the Effectiveness of DermGEN™ in the Treatment of Diabetic Foot Ulcers in First Nations People
A study testing DermGEN™ in people with Diabetes Mellitus and Ulcer Foot, run by DeCell Technologies Inc. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Ulcer Foot, Ulcer Healing
- What is being tested?
- DermGEN™
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 30 Dec 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Northwestern Ontario (NWO) Wound Care Centre of Excellence
Emo, Ontario, P0W 1C0
Joanne Ogden, RN, NSWOC, (807) 486-3407 ext. 214, j.ogden@bellnet.ca
Connie Smith, (807) 486-3407 ext. 212, connie.smith@bellnet.ca
About this study
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
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.
- Conditions
- Diabetes Mellitus, Ulcer Foot, Ulcer Healing, Diabetic Foot Ulcer, Non-healing Wound, Wound of Skin
- Being tested
- Standard of Care, DermGEN™
- 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
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareProcedure or surgery
debridement, wound dressings, offloading
DermGEN™Other
Also called Acellular Dermal Matrix
Decellularized human dermal matrix created from donated human skin
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | 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 Receives: Procedure: Standard of Care |
| DermGEN™ | Experimental | 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. Receives: Other: DermGEN™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.)
Measured: 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.)
Measured: 12 weeks
Incidence of adverse events.
Number of adverse events observed for each arm divided by participants in each arm, reported as a percentage
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 weeks
Secondary outcomes (4)
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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DeCell Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Canadian Institutes of Health Research (CIHR), Dalhousie University, Lakehead University
- Responsible party
- Principal investigator, Dr. Paul F. Gratzer, Dalhousie University
- Investigators
- Paul F Gratzer, Ph.D., Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251480
- Sponsor's protocol ID
- DermGEN.RCT-01
- Status last verified
- Jul 2024
- First submitted
- 3 Nov 2021
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05251480
- Acronym / sponsor ID
- DermGEN.RCT-01
- Conditions
- Diabetes Mellitus, Ulcer Foot, Ulcer Healing, Diabetic Foot Ulcer, Non-healing Wound, Wound of Skin
- Keywords
- Diabetic Ulcer, Diabetic Foot Ulcer, Non-healing Wound, Tissue Engineering, Regenerative Medicine, Decellularized Matrix, Acellular Dermal Matrix, Tissue Allograft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- DeCell Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Canadian Institutes of Health Research (CIHR), Dalhousie University, Lakehead University
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Standard of CareThe 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 |
| DermGEN™ | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Caredebridement, wound dressings, offloading | Procedure or surgery | Standard of Care |
| DermGEN™Also: Acellular Dermal MatrixDecellularized human dermal matrix created from donated human skin | Other | DermGEN™ |
Primary outcome
Mean and median reduction in wound area in the first 4 weeks
Time frame: 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
Time frame: 8 weeks
Proportion with complete healing in the first 8 weeks. (Complete healing is defined as 100% epithelialization without drainage.)
Proportion with complete healing in the first 12 weeks
Time frame: 12 weeks
Proportion with complete healing in the first 12 weeks. (Complete healing is defined as 100% epithelialization without drainage.)
Incidence of adverse events.
Time frame: 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
Time frame: 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.
Impact of Treatment on Wound - LUMT Score
Time frame: 2 weeks
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
Impact of Treatment on Wound - LUMT Score
Time frame: 3 weeks
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
Impact of Treatment on Wound - LUMT Score
Time frame: 4 weeks
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
Impact of Treatment on Wound - LUMT Score
Time frame: 8 weeks
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
Impact of Treatment on Wound - LUMT Score
Time frame: 12 weeks
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
Impact of Treatment on Wound - LUMT Score
Time frame: 20 weeks
Impact of treatment as measured by Leg Ulcer Management Tool (LUMT) score. Comparing initial LUMT score on treatment day 0 to subsequent weeks.
Impact of Treatment on Quality of Life (WoundQoL)
Time frame: 4 weeks
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
Impact of Treatment on Quality of Life (WoundQoL)
Time frame: 8 weeks
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
Impact of Treatment on Quality of Life (WoundQoL)
Time frame: 12 weeks
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
Impact of Treatment on Quality of Life (WoundQoL)
Time frame: 20 weeks
Impact of treatment on Quality of Life using the WoundQoL questionnaire score. Comparison of score on treatment day 0 to subsequent weeks.
4 secondary outcomes
Proportion with complete healing at any time point
Time frame: up to and including 20 weeks post initial treatment (Day 0)
Time to first-measured complete healing
Time frame: up to and including 20 weeks post initial treatment (Day 0)
Mean and median reduction in wound area at 8 weeks
Time frame: 8 weeks
Mean and median reduction in wound area at 12 weeks
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Site for product description, useLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul F Gratzer, Ph.D. principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermGEN™ in people with Diabetes Mellitus and Ulcer Foot, run by DeCell Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Idevania Costa, RN, NSWOC (S), Ph.D (647-230-4742, igcosta@lakeheadu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean and median reduction in wound area in the first 4 weeks (time frame: 4 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.