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

Study Overview
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Brief Summary
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A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)

Detailed Description
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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.

Official Title
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A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcers

Intervention / Treatment
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* Biological: EpiCord
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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 Index Ulcer Assessment: Penetrates down totendon, or bone Presence of another diabetic foot ulcer within 3 cm of the index ulcer Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot Exhibits clinical signs and symptoms of infection Known or suspected local skin malignancy to the index diabetic ulcer Wound duration > one year without intermittent closure Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment: In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer In the last 7 days - Hyperbaric oxygen (HBO) therapy In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy 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 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.) In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s) In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot Subject criteria that will make subject ineligible for enrollment: Known osteomyelitis or active cellulitis at wound site Hemoglobin A1C >12 in the last 60 days prior to randomization History of Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate 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 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) Known history of poor compliance with medical treatments Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited Subjects currently receiving radiation therapy or chemotherapy Patients currently on dialysis or planning to start dialysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EpiCord<br>Weekly application of EpiCord and standard of care (moist wound therapy and offloading) | Biological: EpiCord<br>* Weekly application of EpiCord and standard of care (moist wound therapy and offloading)<br>|
| Active Comparator: Standard of Care<br>Weekly application of moist wound therapy and offloading | Other: Standard of Care<br>* moist wound therapy and offloading<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Ulcer Closure | The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation | 12 weeks | 
| Study Safety Measurement | The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete closure | As assessed by photographic evaluation and the Investigator | up to 12 weeks | 
| Rate of wound closure | As assessed by photographic evaluation and the Investigator | up to 12 weeks | 
| Incidence of ulcer recurrence | Incidence of ulcer recurrence at the site of the study ulcer | up to 12 weeks | 
| Quality of Life Health Survey | Change in quality of life metrics as measured by SF-36 Health Survey | up to 12 weeks | 
| Quality of Life-Pain | Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale | up to 12 weeks | 
| Cost effectiveness of treatment | Cost effectiveness of treatment regime. looking at the number of grafts used on each study subject throughout the study. | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Foot Diseases, Foot Ulcer