dHACM In the Treatment of Diabetic Foot Ulcers

Approximately 20 subjects will be enrolled in this study. Subjects will be seen for up to12 weeks unless 100% epithelialization of the index wound and two subsequent healing confirmation visits have been achieved prior to week 12. Each subject will receive a weekly application of the EpiFix plus standard of care until 100% epithelialization is achieved. The subjects will be evaluated for efficacy and safety during the course of the trial.

Inclusion criteria

• Subject with a DFU that meets all of the following requirements:

• Wound diabetic in origin
• Located on the dorsal or plantar surface of the foot
• Size ranging from 1 to 25 cm2 (Debridement will be done prior to measurement and treatment, if clinically indicated)
• Open a minimum of 30 days prior to treatment (Day 0)
• Failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of offloading and moist wound therapy immediately prior to treatment on Day 0)
• Affected limb must demonstrate adequate circulation, as demonstrated by one of the tests listed below (completed <60 days prior to Day 0)

• Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg; or
• ABIs with results of ≥0.7 and ≤1.2; or
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected foot
• General Subject Characteristics:

• Age 18 or older
• Type 1 or 2 Diabetic (criteria for the diagnosis of diabetes mellitus per ADA)
• Willing and able to provide consent and participate in all procedures necessary to complete the study
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

Exclusion criteria

• DFUs meeting any of the criteria below:

• Non-Index wounds within 2 cm of the index DFU
• Active infection at index DFU
• Index DFU greater than one year in duration without intermittent closure
• DFU is a possible non-revascularizable surgical site
• Known or suspected local skin malignancy to the index diabetic ulcer
• Index DFU treated with biomedical or topical growth factor within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®), EpiFix®, or other scaffold materials (e.g. Oasis®, MatriStem®) within the last 30 days
• Subjects with the following lab values at Day 0:

• HbA1C ≥ 12% at any time within previous 60 days
• Serum Creatinine ≥ 3.0mg/dl within last 6 months
• Therapy Related Exclusions:

• Subjects previously or currently enrolled in this study
• Subjects being treated with investigational drug(s) or investigational therapeutic device(s) within 30 days
• Subjects currently receiving radiation therapy or chemotherapy
• Currently being treated with antibiotics
• Other Exclusion Criteria:

• Active Charcot deformity or major structural abnormalities of the foot
• Known allergy to Gentamicin sulfate or Streptomycin sulfate
• Subjects diagnosed with autoimmune connective tissue diseases
• Any pathology that would limit the blood supply and compromise healing
• Known history of poor compliance with medical treatments
• Subjects who are known to be pregnant, plan to become pregnant, or are breast feeding