Closure of Refractory Complex Lower Extremity Wounds Using a Single Application of a Novel Autologous Homologous Skin Construct in the Clinic Setting; A Clinical Case Series

Background: Chronic lower extremity wounds including diabetic foot ulcers (DFUs) and venous stasis leg ulcers (VLUs) represent an increasing and challenging burden on the health care system, which are often refractory to standard of care combined with advanced wound therapy. Recent innovations in autologous wound therapies have come to the forefront of wound care with the development of a novel autologous homologous skin construct (AHSC) using the patient’s own skin regenerative cellular populations to close difficult to treat wounds. AHSC is a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness, functionally-polarized skin with all of its layers.

Methods: In this case series, 10 patients were evaluated including 5 diabetic foot wounds and 5 venous leg ulcers, all being refractory to at least a month of conservative care. Each patient had an ellipse of full-thickness skin harvested from the proximal calf in the wound clinic and sent to an FDA-registered facility where it was processed into AHSC and returned to the provider within 48 hours. In the wound clinic setting the AHSC was deployed to the wound site evenly and dressed with a silicone based dressing and secured in place with steri-strips and supported with an absorbent foam covered by a triple-layer compression wrap. The patient returned for weekly standard of care dressing changes until documented wound closure.

Results: All of the wound showed progressive healing within 12 weeks and all donor sites remained closed with minimal morbidity reported by the patients.

Conclusion: This clinical case series illustrates a new and unique autograft  warranting further evaluation with randomized controlled trials to validate it success as a wound healing therapy.