Feasibility Study of DermGEN for Diabetic Foot Ulcer Treatment

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:

• 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.