(CS-043) Treatment of Diabetic Foot Ulcers Using Hydrated, Sterile, Ultra-thick Human Amniotic Membrane Allograft

Introduction: Diabetic foot ulcers (DFU) present a substantial clinical and economic burden to healthcare systems, significantly reducing the quality of life of those affected. Despite aggressive treatment with debridement, infection control, dressings, and offloading, 55% of DFUs fail to heal.¹ This is alarming as delayed wound healing is the single most common cause of lower extremity amputation among the diabetic population.^2-5 When DFUs fail to respond to standard of care, skin substitutes and regenerative treatments can be used to support the wound healing process. Ultra-thick human amniotic membrane is one treatment modality that can be used due to its anti-inflammatory and anti-scarring properties, with a key advantage of being readily available without necessitating refrigeration storage.^6-8

Methods: A case series of 3 patients with DFUs who were treated with a fully hydrated, sterile, ultra-thick human amniotic membrane derived from the umbilical cord (AM) allograft^† in the wound clinic without sharp debridement. In brief, the wound was irrigated, and an AM allograft^† was applied without sutures followed by a dressing to maintain moisture control and prevent allograft dislocation.

Results: A 55-year-old male with end-stage renal disease, Peripheral Arterial Disease (PAD), Diabetes Mellitus (DM), and prior transmetatarsal amputation presented with a DFU. Following a single application of AM, robust granulation tissue was noted at 9 weeks. Four additional applications of AM with complete epithelialization noted at 24 weeks. Additionally, a 64-year-old male with hypertension, DM, and sepsis was treated with a single application of AM for a DFU; the wound was filled with granulation tissue by week 3, with complete healing at 7 weeks. A 65-year-old male with DM and PAD presented with a DFU that failed to improve with prior debridement and dressings by an outside physician. Following two applications of AM, complete healing was achieved at 17 weeks.

Discussion: Treatment of DFUs with fully hydrated, sterile, ultra-thick human AM allograft† in the wound clinic resulted in complete wound closure in 7-24 weeks without need for sharp debridement in the operating room. 

Trademarked Items:

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