Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

This is a prospective, multicenter, randomized controlled trial. The trial will include
approximately 66 subjects in up to 10 experienced clinical centers in the United States. The
estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After
completing a 2-week screening period, the subjects will be followed for at least 16 weeks
post-randomization.

Inclusion Criteria:

1. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of
diabetes mellitus per ADA).

2. Index ulcer characteristics:

a. Ulcer present for ≥ 30 days prior to randomization (Day 0) b. Index ulcer is located
below the ankle c. Index ulcer area after debridement is ≥ 1 cm² and ≤ 15 cm² at the
randomization visit 3. Subject has completed 14-day run-in period with ≤ 30% wound area
reduction post-debridement.

4. Subject has adequate circulation to the affected extremity, as demonstrated by one of
the following within the past 60 days:

- Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR

- ABIs with results of ≥ 0.7 and ≤ 1.2, OR

- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the
affected foot 5. Age ≥ 18 6. The subject is willing and able to provide informed
consent and participate in all procedures and follow-up evaluations necessary to
complete the study

1. Index Ulcer Assessment:

1. Penetrates down totendon, or bone

2. Presence of another diabetic foot ulcer within 3 cm of the index ulcer

3. Index ulcer determined to be due to active Charcot deformity or major
structural abnormalities of the foot

4. Exhibits clinical signs and symptoms of infection

5. Known or suspected local skin malignancy to the index diabetic ulcer

6. Wound duration > one year without intermittent closure

2. Prior therapies - Subjects receiving treatment with any of the following will not
be eligible for enrollment:

1. In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of
the index ulcer

2. In the last 7 days - Hyperbaric oxygen (HBO) therapy

3. In the last 10 days - Chemical debridement, Dakin's solution, medical honey
therapy

4. In the last 30 days - Treatment with cytotoxic chemotherapy, application of
topical steroids to the ulcer surface, or use of ≥ 14 days of
immune-suppressants (including systemic corticosteroids); or, subject is
anticipated to require such medications during the course of the study

5. In the last 30 days - study ulcer treatment with any biological skin
substitutes, including EpiCord, biomedical or topical growth factors, tissue
engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold
materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix, Grafix, etc.)

6. In the last 30 days - Subject has been on any investigational drug(s) or
therapeutic device(s)

7. In the last 6 months - Amputation or revascularization (surgical or
stenting) to the affected leg or foot

3. Subject criteria that will make subject ineligible for enrollment:

1. Known osteomyelitis or active cellulitis at wound site

2. Hemoglobin A1C >12 in the last 60 days prior to randomization

3. History of Immune system disorders including Systemic Lupus Erythematosus
(SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV

4. Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate
and/or streptomycin sulfate

5. Presence of any condition (including current drug or alcohol abuse, medical
or psychiatric condition) that is likely to impair understanding of or
compliance with the study protocol in the judgment of the Investigator

6. Pregnancy at enrollment or within last 6 months, women who are
breastfeeding, or women of childbearing potential who are planning to become
pregnant during the time of the study OR are unwilling/unable to use
acceptable methods of contraception (birth control pills, barriers, or
abstinence)

7. Known history of poor compliance with medical treatments

8. Subjects currently enrolled in this study. Concurrent enrollment in the
study is prohibited

9. Subjects currently receiving radiation therapy or chemotherapy

10. Patients currently on dialysis or planning to start dialysis