Focus of the Report: This report compares the effectiveness and safety of acellular skin substitutes as an addition to standard wound care (SWC) compared with SWC alone and compared with the use of cellular skin substitutes to treat chronic or nonhealing diabetic foot ulcers (DFU) in adults with diabetes mellitus (DM).

Technology Description: Skin substitutes are proposed as an adjunct treatment to cover open chronic ulcers and promote wound healing, with the goals of preventing infection and amputation. They are thought to function by physically covering the wound and providing extracellular matrices to induce regeneration and immune function. Skin substitutes, also known as bioengineered, tissue-engineered, or artificial skin, are heterogeneous and can generally be classified into 2 main types: cellular (comprising living cells); or acellular (composed of synthetic materials or of tissues from which living cells have been removed). Regardless of the source, the skin substitute provides a matrix into which cells can migrate. Skin substitutes are characterized as autografts, allografts, xenografts, and bioengineered or artificial skin. This report focuses on acellular skin substitutes.

Controversy: Skin substitutes are a heterogeneous group of tissue replacements and skin grafts sourced from different materials and subject to different regulatory pathways. Many are very costly. The relative value of different skin substitutes for treating diabetes-associated foot ulcers is unclear.

Key Questions:

For the adjunct treatment of chronic foot ulcers in adults with DM:

  • Compared with SWC alone, what is the efficacy of acellular skin substitutes in terms of incidence of amputation, incidence of complete ulcer healing, time to complete ulcer healing, and quality of life?

  • What complications are associated with acellular skin substitutes?

  • Do efficacy and safety differ by acellular skin substitute type or specific product or compared with cellular skin substitutes?

  • Have definitive patient selection criteria been established for acellular skin substitutes for DFUs?

If you have a Hayes login, click here to view the full report on the Knowledge Center.