Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.

Official Title
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A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Other: Standard of Care: Moist Wound Therapy and Offloading
* Other: EpiFix plus Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age 18 or older. The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study. Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2. Debridement will be done prior to randomization, if clinically indicated. Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot. Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA). Ulcer must be present for a minimum of 30 days before enrollment/randomization, with documented failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of therapy immediately prior to randomization when treated with standard protocol of care). Affected leg has been offloaded (removable walker or total contact cast) for >14 consecutive days prior to randomization. Serum Creatinine less than 3.0mg/dl (within last 6 months). HbA1c less than 12% within previous 60 days. Patient 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 ≥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. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). Exclusion Criteria: Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-tobone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe. Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care. Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days. Known history of poor compliance with medical treatments. Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited. Patients treated with investigational drug(s) or therapeutic device(s) within 30 days. Patients currently receiving radiation therapy or chemotherapy. Known or suspected local skin malignancy to the index diabetic ulcer. Patients diagnosed with autoimmune connective tissue diseases. Non-revascularizable surgical sites. Active infection at index site or currently being treated with antibiotics Any pathology that would limit the blood supply and compromise healing. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days. Patients who are known to be pregnant, plan to become pregnant, or are breast feeding. Known allergy to Gentamicin sulfate or Streptomycin sulfate. Active Charcot deformity or major structural abnormalities of the foot. Wounds that are greater than one year in duration without intermittent closure.

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 |
| --- | --- |
| Other: Control<br>Standard of Care: Moist Wound Therapy and Offloading | Other: Standard of Care: Moist Wound Therapy and Offloading<br>* Standard of Care: Moist Wound Therapy and Offloading<br>|
| Experimental: EpiFix plus Standard of Care<br>Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading) | Other: EpiFix plus Standard of Care<br>* Weekly application of EpiFix and Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with complete closure of the study ulcer | Assessed by the Investigator, during treatment (Visits 1 - 13). | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete closure for both groups | 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 Week 12 | 
| Incidence of ulcer recurrence | Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase. | Up to Week 16 | 
| Quality of Life | Change in quality of life metrics as measured by SF-36 Health Survey and changes in the patient's reported pain scores as measured by the Visual Analog Scale. | Up to Week 12 | 
| Cost effectiveness of treatment | Cost effectiveness of treatment regimen. | Up to Week 12 |