Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02184455
Recruitment Status : Recruiting
First Posted : July 9, 2014
Last Update Posted : October 11, 2016
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Information provided by (Responsible Party):
Dr. Paul F. Gratzer, DeCell Technologies Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Type I Diabetes Type II Biological: DermGEN Phase 1

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers
Study Start Date : August 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Mean and Median Wound Size [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Proportion with Complete Healing at any time point [ Time Frame: 20 weeks ]
    Complete healing is defined as 100% epithelialization without drainage

  2. Incidence of adverse events [ Time Frame: 20 weeks ]
  3. Incidence of reoccurrence after complete healing [ Time Frame: 20weeks ]
  4. Change in wound characteristic [ Time Frame: 20 weeks ]
  5. Percent Change in Wound Area [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02184455

Contact: Trish Francis, RN (902) 473-5993
Contact: Paul Gratzer, Ph.D. (902) 494-3015

Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada, B3H3A7
Principal Investigator: Mark Glazebrook, PhD,MD,FRSC         
Sub-Investigator: Jason G Williams, MD,FRCSC         
Sub-Investigator: Martin R LeBlanc, MD,FRCS(C)         
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ryan M Khan, CCRP    (416) 864-6060 ext 3890   
Contact: Timothy R Daniels, MD, FRSC    (416) 864-5392   
Principal Investigator: Timothy R Daniels, MD, FRSC         
Sponsors and Collaborators
Dr. Paul F. Gratzer
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Principal Investigator: Mark Glazebrook, PhD,MD Queen Elizabeth II Health Sciences Center

Responsible Party: Dr. Paul F. Gratzer, CEO, DeCell Technologies Inc. Identifier: NCT02184455     History of Changes
Other Study ID Numbers: DeCell-001
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by Dr. Paul F. Gratzer, DeCell Technologies Inc.:
Chronic Ulcer
Wound Healing

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Foot
Foot Ulcer
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies
Foot Diseases
Autoimmune Diseases
Immune System Diseases