Bioengineered alternative tissues in diabetic wound healing.

Area of Science:

• Regenerative Medicine
• Biomaterials
• Wound Healing

Background:

• Biologic advanced therapies (BATs) offer novel approaches to improve patient outcomes.
• Significant progress has been made in treating diabetic wounds with BATs.
• Current literature predominantly features small studies, lacking robust evidence.

Purpose of the Study:

• To evaluate the current evidence for biologic advanced therapies (BATs) in diabetic wound healing.
• To highlight the need for rigorous clinical trials for emerging BATs, including those using mesenchymal stem cells (MSCs).

Main Methods:

• Literature review of existing studies on BATs for diabetic wound healing.
• Analysis of the quality and robustness of evidence from pivotal trials and smaller case series.
• Assessment of the potential of advanced BATs, such as MSC-based therapies.

Main Results:

• Pivotal trials for BATs were conducted over a decade ago.
• A lack of robust, high-quality evidence supports the current use of many BATs.
• Advanced BATs, including MSCs, show potential but require stringent investigation.

Conclusions:

• Fundamental diabetic foot ulcer (DFU) care (perfusion, off-loading, debridement) remains crucial.
• More rigorous research is needed to validate the efficacy and safety of advanced BATs.
• Future advancements in BATs for diabetic wound healing require a foundation of strong clinical evidence.