Bioactive Split Thickness Skin Allograft Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

This study is a prospective, multi-center, Randomized Controlled Trial ( RCT ) designed to assess performance and safety and collect patient outcome data on a commercially available human split thickness skin allograft (Theraskin™) with SOC dressing compared to SOC dressings alone in the treatment of Diabetic Foot Wounds (DFU) . The study will last thirteen weeks, with a two week screening period prior to enrollment. Theraskin™ is an allograft tissue and will be used in compliance with homologous use by the FDA under section 361 of the PHS Act and 21 CFR Part 1271.

There are two arms in the study:

Arm 1: The Experimental Arm , that will include SOC Therapy. SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and application of human split thickness skin allograft (Theraskin™) followed by a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent).

Arm 2: The Standard of Care Arm. The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a moisture retentive dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Inclusion criteria

• At least 18 years old.
• Presence of a DFU, Wagner Grade 1 (see Appendix A for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.
• The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
• Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
• Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of > 0.6 is acceptable.
• The target ulcer has been offloaded for at least 14 days prior to randomization.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits

Exclusion criteria

• Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
• Subjects taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
• History of radiation at the ulcer site (regardless of time since last radiation treatment).
• Index ulcer has been previously treated or will need to be treated with any prohibited therapies.
• Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
• Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
• Subject is pregnant or breast-feeding.
• Presence of diabetes with poor metabolic control as documented with an HbA1c >12.0 within last 90 days of randomization.
• Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of randomization.
• Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.