Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

NCT02184455 | Completed Phase 1 Results DMC

• 1 other identifier: DeCell-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Type I; Diabetes Type II

Keywords

Diabetic; Chronic Ulcer; Wound Healing; Leg

Outcome Measures

Primary Outcomes (1)

• Percentage of Wound Area Reduction Compared to Baseline

  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 Outcomes (5)

• Percentage of Patients With Complete Healing at Any Time Point

  20 weeks

• Number of Patients With Adverse Events

  20 weeks

• Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing

  1 year

• Percent Change in Wound Size Compared to Baseline

  20 weeks

• Percent Change in Wound Area From Baseline

  12 Weeks

Study Arms (1)

DermGEN Decellularized Dermal Matrix

EXPERIMENTAL

DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.

Biological: DermGEN

Interventions

DermGEN BIOLOGICAL

DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.

DermGEN Decellularized Dermal Matrix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with documented stable Type I or II diabetes (HbA1C \>7.0 within 1 month prior to Day 0).
• Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.
• Study ulcer has healed \<30% in size during the 2 weeks prior to Day 0.
• Ulcer area is ≥1 cm2 prior to debridement 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 on Day 0.
• 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.
• 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.

You may not qualify if:

• 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.
• 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, serum albumin \<2.0 gm/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 ongoing cellulitis or osteomyelitis
• Patient has any other condition which seriously compromises their ability to complete the study
• Patient has known allergies to antibiotics, such as penicillin and streptomycin
• Patient has a history of bleeding disorder

Sponsors & Collaborators

• Dr. Paul F. Gratzer: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Nova Scotia Health Authority: collaborator

Study Sites (2)

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H3A7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

This study was a low numbered, one-arm, safety and feasibility study. No statistical analyses for superiority were intended nor attempted.

Results Point of Contact

• Title: Dr. Paul F. Gratzer, CSO
• Organization: DeCell Technolpogies Inc.

pfgratzer@decelltechnologies.com

902-223-2179

Study Officials

• Mark Glazebrook, PhD,MD

  Queen Elizabeth II Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Model Details: Diabetic type I/II patients with chronic ulcer present

Study Record Dates

• First Submitted: July 3, 2014
• First Posted: July 9, 2014
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 24, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-09

Locations

CA (2)