Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by DeCell Technologies Inc.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Capital District Health Authority, Canada
Information provided by (Responsible Party):
Dr. Paul F. Gratzer, DeCell Technologies Inc.
ClinicalTrials.gov Identifier:
NCT02184455
First received: July 3, 2014
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

The purpose of this clinical trial is to perform a limited pilot study to determine the 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 ]
  • Percent Change in Wound Area [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Proportion with Complete Healing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Complete healing is defined as 100% epithelialization without drainage


Secondary Outcome Measures:
  • Proportion with Complete Healing [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Complete healing is defined as 100% epithelialization without drainage

  • Time to Complete Healing [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Complete healing is defined as 100% epithelialization without drainage

  • Incidence of Recurrence [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Incidence of Adverse Events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Wound Characterization [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Mean and Median Wound Size [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: January 2015 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with documented stable Type I or II diabetes (HbA1C confirmation every 4 months)
  • Patient's ulcer is present for a minimum of 2 weeks under Investigator's care
  • Study ulcer has healed <50% in size during 2 weeks leading up to enrollment
  • Study ulcer is on plantar surface of the foot
  • Ulcer ≥1 cm2 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 necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting 2 weeks after initial presentation
  • Patient has adequate circulation to the foot as evidenced by palpable pulse
  • Ankle-Brachial Index (ABI) and Toe-Brachial Index (TBI) of ≥0.7? (mild to moderate obstruction)
  • Female patients are not pregnant at time of, or during study
  • Patient and caregiver ready and willing to participate and comply with follow-up regime
  • Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form

    • - ulcer usually presents as around 1 cm2 but is greater after debridement

Exclusion Criteria:

  • Evidence of gangrene on affected foot
  • Ulcer is over Charcot deformity (fractures or dislocation)
  • Ulcer is non-diabetic in etiology
  • Ulcer has tunnels or sinus tracts that cannot be completely debrided
  • Patient's HgA1C < 12
  • Medical condition(s) that in the Investigator's opinion make the patient inappropriate for study
  • Patient has/had malignant disease not in remission for 5 years or more
  • Patient has acute or chronic Hepatitis, Cirrhosis, has serum albumin <2.0 gms/dL, or has alkaline phosphatase or LDH at twice the normal upper limit
  • Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study
  • Patient received radiation therapy within 30 days of Day 0 of study
  • Patient has AIDS or is infected with HIV
  • Patient has participated in another study using investigational drug(s) or device within the previous 30 days
  • Obvious clinical signs and symptoms of cellulitis and osteomyelitis
  • Patient has any other conditions which seriously compromises their ability to complete the study
  • Patient has known allergies to antibiotics such as Penicillin and Streptomycin
  • Patient has history of bleeding disorder
  • Patient received elective osseous procedures to study foot with 30 days prior to screening visit
  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 Patricia.Francis@cdha.nshealth.ca
Contact: Karl Conlan (902) 442-4668 kconlan@decelltechnologies.com

Locations
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center Not yet recruiting
Halifax, Nova Scotia, Canada, B3H3A7
Principal Investigator: Mark Glazebrook, PhD, Dip sports Med., MD,FRSC         
Sub-Investigator: Jason G Williams, MD MEd FRCSC         
Sub-Investigator: Martin R LeBlanc, MD, FRCS(C)         
Sponsors and Collaborators
Dr. Paul F. Gratzer
Canadian Institutes of Health Research (CIHR)
Capital District Health Authority, Canada
Investigators
Principal Investigator: Mark Glazebrook, MSc, PhD, Dip sports Med., MD Queen Elizabeth II Health Sciences Center
  More Information

No publications provided

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: July 30, 2014
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 21, 2014