Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

September 13, 2019 updated by: Dr. Paul F. Gratzer

A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers

The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will result in positive healing outcomes with no significant adverse effects.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This will be a one-arm prospective study. This study in Halifax will be mirrored in one other participating health care center in Toronto, Ontario, Canada with each centre anticipated to enrol 5-10 patients for a total of 15-20 patients.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Queen Elizabeth II Health Sciences Center
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied:

  1. Patient with documented stable Type I or II diabetes (HbA1C >7.0 within 1 month prior to Day 0).
  2. Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.
  3. Study ulcer has healed <30% in size during the 2 weeks prior to Day 0.
  4. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.
  5. Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule.
  6. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0.
  7. Patient has adequate circulation to the foot as evidenced by palpable pulse or pulse detectable with Doppler ultrasound, and lack of visible cyanosis in skin bordering the ulcer.
  8. Female patients are not pregnant at time of, or during study.
  9. Patient and caregiver ready and willing to participate and comply with follow-up regime.
  10. Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form.

Exclusion Criteria:

A subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied:

  1. Evidence of gangrene on affected foot.
  2. Ulcer is over Charcot deformity (fractures or dislocation).
  3. Ulcer is non-diabetic in etiology.
  4. Ulcer has tunnels or sinus tracts that cannot be completely debrided.
  5. Medical condition(s) that in the Investigator's opinion make the patient inappropriate for study
  6. Patient has/had malignant disease not in remission for 5 years or more
  7. Patient has acute or chronic hepatitis, cirrhosis, serum albumin <2.0 gm/dL, or has alkaline phosphatase or LDH at twice the normal upper limit
  8. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study
  9. Patient received radiation therapy within 30 days of Day 0 of study
  10. Patient has AIDS or is infected with HIV
  11. Patient has participated in another study using investigational drug(s) or device within the previous 30 days
  12. Obvious clinical signs and symptoms of ongoing cellulitis or osteomyelitis
  13. Patient has any other condition which seriously compromises their ability to complete the study
  14. Patient has known allergies to antibiotics, such as penicillin and streptomycin
  15. Patient has a history of bleeding disorder
  16. Patient received elective osseous procedures to the study foot within 30 days prior to screening visit, except that patients whose DFU overlies an area of treated osteomyelitis may be included, providing there exists a suitable base for application of the DermGEN.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DermGEN Decellularized Dermal Matrix
DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Wound Area Reduction Compared to Baseline
Time Frame: 4 weeks
Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients With Complete Healing at Any Time Point
Time Frame: 20 weeks
Complete healing is defined as 100% epithelialization without drainage. Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100.
20 weeks
Number of Patients With Adverse Events
Time Frame: 20 weeks
Reporting the number of patients participating in the study having adverse events
20 weeks
Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing
Time Frame: 1 year
Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment.
1 year
Percent Change in Wound Size Compared to Baseline
Time Frame: 20 weeks
Digital photography was utilized to capture the appearance and size of the ulcer at each visit. In the photograph a measurement scale was shown beside the wound. The area of the wound was calculated by manually outlining wound edges on a digital image and then using the open source program ImageJ to calculate the area of the wound. For calculating the percentage change in area of the wound, the wound areas at each time point were divided by the size of the wound at baseline and multiplied by 100. Note 100% equals complete closure of the wound.
20 weeks
Percent Change in Wound Area From Baseline
Time Frame: 12 Weeks
change in area of wound in percent from initial presentation
12 Weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Mark Glazebrook, PhD,MD, Queen Elizabeth II Health Sciences Center

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 (Actual)

July 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 3, 2014

First Submitted That Met QC Criteria

July 8, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

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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