Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

Study Overview
=================
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.

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.

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

Conditions
-----------------
Diabetes Type I, Diabetes Type II

Intervention / Treatment
-----------------
* Biological: DermGEN


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A subject will be considered eligible to participate in this study if each of the following inclusion criteria is satisfied: 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. Exclusion Criteria: A subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied: 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Diabetic type I/II patients with chronic ulcer present
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DermGEN Decellularized Dermal Matrix<br>DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue. | Biological: DermGEN<br>* DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Complete Healing at Any Time Point | Complete healing is defined as 100% epithelialization without drainage. 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. | 20 weeks | 
| Number of Patients With Adverse Events | Reporting the number of patients participating in the study having adverse events | 20 weeks | 
| Number of Patients With Ulcer Reoccurrence in the Same Location After Complete Healing | Number of patients that reported a reoccurrence of the ulcer in the same location after complete healing at 1 year post treatment. | 1 year | 
| Percent Change in Wound Size 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. Note 100% equals complete closure of the wound. | 20 weeks | 
| Percent Change in Wound Area From Baseline | change in area of wound in percent from initial presentation | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic, Chronic Ulcer, Wound Healing, Leg