45-LB: Results of a Pilot Evaluation of a Novel Autologous Homologous Skin Construct Treatment of Diabetic Foot Wounds Refractory to Conventional Treatments

Abstract

Background: An autologous homologous skin construct (AHSC) has been developed to treat complex cutaneous wounds (burns, chronic defects, and acute trauma) and was evaluated for treating diabetic foot ulcers (DFUs). Methods: AHSC was manufactured from 1.5cm2 healthy full-thickness skin harvest. All of the tissue is utilized and the endogenous regenerative populations are activated during processing. It is spread evenly across the wound bed and dressed similar to an autologous skin graft. Eleven Wagner 1 and Wagner 2 DFUs refractory to conventional therapies including advanced wound care products were treated with a single application of AHSC. Results: All harvests and deployments were performed in the outpatient setting. Wounds were dressed with silicone, compression bolster, and off-loading for the first 3 weeks followed by standard of care until closure. All harvest sites were primarily closed with no complications. All 11 wounds demonstrated complete graft take with one application. One patient with prior lower extremity hardware developed an infection separate from the AHSC-treated wound requiring extensive debridement including the treated wound. The remaining 10/11 wounds were closed by 10 weeks with a median of 5.8 weeks. Wounds remained closed at 2-week post-closure follow-up. There were no adverse events related to the AHSC treatments. Conclusions: AHSC was able to close DFUs refractory to standard of care with one treatment utilizing normal clinic work flow and requiring only one application. Further evaluation with randomized controlled trials are warranted. Disclosure C. Zelen: Research Support; Self; Musculoskelatal Transplant Foundation, Polarity TE. D.G. Armstrong: None.