Use of a High-Dose ECM for the Management of Deep Diabetic Foot Ulcers: A Case Series

According to the National Diabetes Statistics Report, over 30 million people in the USA (9.4% of the population) are living with diabetes. Diabetic foot ulcers (DFUs) are chronic nonhealing wounds that affect 15–25% of all diabetic patients in their lifetime and are estimated to cost the health system $9–13 billion per year. Moreover, uncontrolled DFUs are a major cause of lower extremity amputation, which resulted in over 100,000 hospitalizations in 2014, and leads to a 45–55% mortality rate over five years post-amputation.

The cost, prevalence, and mortality associated with DFUs is in partly due to the chronicity of the wound, which remains in a stalled inflammatory state and cannot easily close without intervention. Early wound care options for DFUs include surgical debridement, wound dressing, and antibiotics. Advanced dressings that reverse the wound chronicity at an early stage can save money, live,s and the quality of life for patients.

An ovine extracellular matrix scaffold (ECM) provides over 151 native ECM proteins, including collagen, laminin, glycosaminoglycans, and other components that help to control the inflammatory response and then support the deposition and organization of new granulation tissue. Because the ECM is fabricated with increased volume, it can be utilized in deep wounds to restore protease balance, as well as serve as a scaffold to build granulation tissue. In this case series, ECM was applied to diabetic patients (n=4) with deep foot ulcers ranging in size from 1–7.5 cm.

At each weekly assessment, the wound area was measured, and characteristics were noted (granulation tissue, surrounding scar tissue). All wounds had closed after a period of 8–12 weeks of treatment.