Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

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

NCT02184455•Dr. Paul F. Gratzer

Summary

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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
+6 more criteria

Locations (2)

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

July 1, 2016

Primary Completion Date

May 1, 2017

Completion Date

May 1, 2017

Last Updated

September 24, 2019

Enrollment

ACTUAL participants

Conditions

Diabetes Type IDiabetes Type II

Interventions

DermGEN

BIOLOGICAL

Novel Biomarker for Development of T2D

NCT02326129

Diabetes Type II

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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