Use of hypothermically stored amniotic membrane on diabetic foot ulcers: microbiological, immunological, clinical and therapeutic distinctions

02 March 2024
Volume 8 · Issue 1



The aim of this retrospective case series was to report on the outcomes of diabetic foot ulcers (DFUs) managed with hypothermically stored amniotic membrane (HSAM).


Deidentified case data of patients who received HSAM were obtained from wound care sites across the US. Data were collected, beginning at the first patient visit to the wound care site (first presentation), at the visit in which the first HSAM application occurred (baseline), and at each subsequent visit over 12 weeks of treatment (follow-up). All patients received standard of care (SoC) between first presentation and baseline. Results: Of the 50 patients in the study, 68% were male. Mean age of the entire cohort was 66.7 years. Of the DFUs, 88% were present for <6 months at first presentation. Mean wound area was 3.5cm2, and mean percentage area reduction was −68.3% from first presentation to baseline. The mean number of HSAM applications was 5.5, and mean number of days between applications was 7.5. A >60% area reduction was attained in 96.0% of DFUs, and 78% attained complete wound closure (CWC) by week 12. The median time to CWC was 55 days.


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

Hard-to-heal (chronic) wounds place a major burden on the healthcare system within the US. An estimated 15% of Medicare beneficiaries (8.2 million individuals) had some form of a hard-to-heal wound.1 This approximates to an annual expenditure of ~$28–97 billion USD, depending on primary and secondary diagnoses.1

On an individual basis, average annual Medicare spending for a hard-to-heal wound ranges from ~$3,400–11,800 USD.1 However, many hard-to-heal wounds fail to heal and can significantly increase the cost of treatment. A venous leg ulcer (VLU) may cost an individual up to $19,000 USD annually due to recurrent treatment,2 while a diabetic foot ulcer (DFU) may lead to amputation, costing an estimated ~$38,000–$54,000.3

In addition to the financial burden, hard-to-heal wounds place many limitations on patient lifestyle and negatively impact quality of life (QoL). Complications such as pain, odour, pruritus and exudate can result in negative social and emotional outcomes.3 Both may lead to non-adherence with care, resulting in worsening wound status, increased costs for additional treatment, potential job loss and, ultimately, further reduced QoL.4

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