Health Problem: Diabetes mellitus (DM) can damage blood vessels, compromising blood flow and oxygen circulation. Resulting tissue hypoxia may contribute to failure of even minor wounds to heal. Chronic foot ulcers in people with DM (DFU) may occur when foot injuries, such as cuts, blisters, or sores, develop, worsen, and do not heal. Reasons are multifactorial and may include compromised sensation due to diabetes-related nerve damage and poor blood flow due to diabetes-related blood vessel damage.

Technology Description: Skin substitutes are proposed as an adjunct treatment to standard wound care (SWC) 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 (comprised of living cells); or acellular (composed of synthetic materials or tissue from which living cells have been removed). Regardless of the source, the skin substitute provides a matrix into which cells can migrate. This report focuses on cellular 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 is unclear.

Key Questions:

For the adjunct treatment of chronic DFU in adults with DM:

  • Compared with SWC alone, what is the efficacy of cellular skin substitutes added to SWC 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 cellular skin substitutes?

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

  • Have definitive patient selection criteria been established for cellular skin substitutes for DFU?

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