Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

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

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.

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.

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.