(CS-135) Use of Hypothermically Stored Amniotic Membrane on Diabetic Foot Ulcers: A Multicenter Retrospective Case Series

Alan Hartstein, DPM, FACFAS, DABWM – Podiatrist, Palm Beach Foot and Ankle; Hisham Ashry, DPM, MS, FACFAS, CWS – Podiatrist, Palm Beach Foot and Ankle; Maryam Raza, MD, CWSP – Medical Director, Wound Care and Hyperbaric Center, Methodist Dallas Medical Center

Introduction:

Diabetic foot ulcers (DFUs) are one of the most common types of chronic wounds.¹ The pathophysiology of DFU’s is multifactorial, stemming from conditions such as neuropathy, vasculopathy, immunopathy, deformity and mechanical stress. Diabetes-related ulcers requiring amputation carry a 5-year mortality risk that is higher than many common forms of cancer,² presenting a considerable health care burden and impact to patient quality of life.³ In a prospective, randomized controlled trial comparing the efficacy of Hypothermically Stored Amniotic Membrane (HSAM)^(a) plus standard of care (SOC) to SOC alone, HSAM demonstrated a significantly higher frequency of and decreased time to wound closure.⁴ The aim of this multicenter, retrospective case series is to expand on this knowledge and report on the outcomes of DFUs receiving HSAM.

Methods:

Deidentified case data of 50 patients who received HSAM as part of the course of treatment for a DFU were obtained from wound care sites across the US. Data was collected beginning at the first visit of the patient to the wound care site (first presentation), at the visit in which first HSAM application occurred (baseline), and at each subsequent visit over the 12 weeks of treatment (follow-up). All patients received standard of care (SOC) treatment between first presentation and baseline.

Results:

Most patients in the study were male (68%) with the mean age of the entire cohort being 66.7 years. Eighty-eight percent of DFUs were present for < 6 months at first presentation. The cohort had a mean wound area of 3.5 cm² and had a mean percent area reduction of -68.3 % from first presentation to baseline. The mean number of HSAM applications was 5.5 and the mean interval of time between each application was 7.5 days. Ninety-six percent of DFU’s in the study attained >60% area reduction and 78% attained complete wound closure (CWC) by Week 12. The median time to CWC was 55 days.

Discussion:

The results of this retrospective case series suggest positive outcomes for DFUs receiving HSAM. A reduction in time to CWC may lead to lesser financial burden and improved quality of life for DFU patients.