Prospective, Comparitive, Randomized Study of Allograft Versus Skin Substitute in Non-healing Diabetic Foot Ulcers

2016-08-19 11:25:05 | BioPortfolio


The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs).


Diabetes affects at least 9% of the population, or approximately 29 million people in the United States. Lower extremity ulcers are a serious complication for people with diabetes. Diabetic foot-related problems are the most frequent cause of hospitalization within this group and it is estimated that the total cost for treatment ranges from $10,000 to nearly $60,000 depending on ulcer severity and clinical outcomes. While many diabetic foot ulcers are superficial and can heal with conservative treatment, many are more severe and recalcitrant to standard of care (SOC). About a quarter of individuals with diabetes will develop a chronic non-healing ulcer over their lifetime and nearly 60 of every 10,000 individuals with diabetes will undergo a lower extremity amputation. Holzer and associates conducted a retrospective analysis of the costs for lower extremity ulcers in patients with diabetes and concluded that, given the high costs associated with treating these ulcers, the development of better treatment strategies is warranted. One such development in the treatment of chronic wounds is the use of amniotic membrane grafts. These materials have been used successfully for many years in the treatment of orthopedic, plastic/reconstructive, and urological applications. Initial studies have demonstrated the great success of amnionic membrane graft in the healing of chronic diabetic foot ulcers and it is believed that these grafts may be superior to older, more common skin substitutes.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Diabetic Foot Ulcer


Dressing Application, Offloading


Martinsville Research Institute
United States




Professional Education and Research Institute

Results (where available)

View Results


Published on BioPortfolio: 2016-08-19T11:25:05-0400

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Medical and Biotech [MESH] Definitions

Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.

Lesion on the surface of the skin of the foot, usually accompanied by inflammation. The lesion may become infected or necrotic and is frequently associated with diabetes or leprosy.

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.

Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Devices used to support or align the foot structure, or to prevent or correct foot deformities.

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