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Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by DeCell Technologies Inc.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Information provided by (Responsible Party):
Dr. Paul F. Gratzer, DeCell Technologies Inc.
ClinicalTrials.gov Identifier:
NCT02184455
First received: July 3, 2014
Last updated: October 10, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Diabetes Type I
Diabetes Type II
Biological: DermGEN
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Study of DermGEN Dermal Regeneration Scaffold for the Treatment of Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by DeCell Technologies Inc.:

Primary Outcome Measures:
  • Mean and Median Wound Size [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion with Complete Healing at any time point [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
    Complete healing is defined as 100% epithelialization without drainage

  • Incidence of adverse events [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of reoccurrence after complete healing [ Time Frame: 20weeks ] [ Designated as safety issue: Yes ]
  • Change in wound characteristic [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Percent Change in Wound Area [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02184455

Contacts
Contact: Trish Francis, RN (902) 473-5993 Trish.Francis@nshealth.ca
Contact: Paul Gratzer, Ph.D. (902) 494-3015 pfgratzer@decelltechnologies.com

Locations
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    khanry@smh.ca   
Contact: Timothy R Daniels, MD, FRSC    (416) 864-5392    danielst@smh.ca   
Principal Investigator: Timothy R Daniels, MD, FRSC         
Sponsors and Collaborators
Dr. Paul F. Gratzer
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Authority
Investigators
Principal Investigator: Mark Glazebrook, PhD,MD Queen Elizabeth II Health Sciences Center
  More Information

Responsible Party: Dr. Paul F. Gratzer, CEO, DeCell Technologies Inc.
ClinicalTrials.gov Identifier: NCT02184455     History of Changes
Other Study ID Numbers: DeCell-001 
Study First Received: July 3, 2014
Last Updated: October 10, 2016
Health Authority: Canada: Health Canada

Keywords provided by DeCell Technologies Inc.:
Diabetic
Chronic Ulcer
Wound Healing
Leg

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Foot
Foot Ulcer
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
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

ClinicalTrials.gov processed this record on December 08, 2016