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

July 2, 2024 updated by: Dr. Paul F. Gratzer, DeCell Technologies Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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.)
8 weeks
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.)
12 weeks
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
Reports included at any time up to and including 20 weeks post treatment.
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.
1 week
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.
2 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.
3 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.
4 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.
8 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.
12 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.
20 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.
4 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.
8 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.
12 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.
20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion with complete healing at any time point
Time Frame: 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
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)
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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DeCell Technologies Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Dalhousie University
Lakehead University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul F Gratzer, Ph.D., Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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