dHACM Mesh 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 Mesh 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:

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

A. Wound diabetic in origin B. Located on the dorsal or plantar surface of the foot
C. Size ranging from 1 to 25 cm2 (Debridement will be done prior to measurement and
treatment, if clinically indicated) D. Open a minimum of 30 days prior to treatment
(Day 0) E. 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)

2. 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

3. General Subject Characteristics:

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

Exclusion Criteria:

1. DFUs meeting any of the criteria below:

A. Non-Index wounds within 2 cm of the index DFU B. Active infection at index DFU C.
Index DFU greater than one year in duration without intermittent closure D. DFU is a
possible non-revascularizable surgical site E. Known or suspected local skin
malignancy to the index diabetic ulcer F. 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®
Mesh, EpiFix®, or other scaffold materials (e.g. Oasis®, MatriStem®) within the last
30 days

2. Subjects with the following lab values at Day 0:

A. HbA1C ≥ 12% at any time within previous 60 days B. Serum Creatinine ≥ 3.0mg/dl
within last 6 months

3. Therapy Related Exclusions:

A. Subjects previously or currently enrolled in this study B. Subjects being treated
with investigational drug(s) or investigational therapeutic device(s) within 30 days
C. Subjects currently receiving radiation therapy or chemotherapy D. Currently being
treated with antibiotics

4. Other Exclusion Criteria:

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