Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.

Diabetic Foot Ulcer

Diabetes, Diabetic Foot, Allograft, Amnion, Chorion, Wound healing, Advanced wound care, Comparative effectiveness, Lower extremity ulcer, Time to heal, Treatment, Diabetes complication, Skin ulcer, Neuropathy, Peripheral artery disease, Ischemia, Wagner Grade

The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does the use of perinatal tissue allografts in conjunction with standard of care wound management techniques result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly 1) applications of perinatal tissue allografts and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.

Patients with diabetes often develop ulcers on their lower extremities. While some ulcers can be managed using standard of care wound management techniques including debridement, moist dressings, infection control and off-loading, many develop into chronic, non-healing wounds. Chronic non-healing wounds can lead to higher risk of infection, amputation and decreased quality of life. Advanced wound therapies aim to promote rapid and complete healing of chronic wounds. An example of an advanced wound therapy are perinatal tissue allografts. These include human amniotic / chorionic membranes, which have been confirmed by the United States Food & Drug Administration's Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the Public Health Service Act as defined in Title 21 of the Code of Federal Regulations - Part 1271 for the management of diabetic foot ulcers. The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of perinatal tissue allografts in addition to standard of care wound management techniques compared to applying standard of care wound management only. It is hypothesized that the addition of perinatal tissue allografts to standard of care treatment will result in a higher percentage of ulcers achieving complete closure (i.e. healing) compared to ulcer being treated with standard of care alone after 12 weeks of treatment. To test this hypothesis the study will consist of patients who will undergo a 2-week screening phase and a 12-week treatment phase. Briefly, during the 2-week screening phase, patients meeting inclusion criteria will have an identified index wound managed with standard of care. Index wounds that are not reduced by more than 20% in the screening phase will be randomized into the treatment groups. During the 12-week treatment phase, index wounds will be treated weekly with either allograft and standard of care or standard of care alone. Evaluation of data (outcome measures) associated with the trial will include intent to treat and per protocol analyses which will be performed by at least one blinded statistician and investigator.

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