Pilot Study Assessing Novel Autologous Homologous Skin Construct Treatment of Nonhealing Diabetic Foot Wounds

Introduction: Diabetic foot ulcers (DFUs) are a significant burden on the worldwide health-care system. These chronic lower extremity wounds are often refractory to standard of care and can result in lower extremity amputation. A novel autologous homologous skin construct (AHSC) using the patient’s dermal regenerative cellular populations was evaluated in a pilot study for the treatment of DFUs.

Methods: Eleven patients with DFUs refractory to at least a month of conservative care were treated with a single application of AHSC. A 1.5 cm² proximal calf harvest of full-thickness skin was collected in the clinic and sent to an FDA-registered facility, where it was processed into AHSC and returned to the provider within 48 hours. AHSC was spread evenly across the wound, dressed with silicone, secured with steri-strips, and bolstered with an absorbent foam covered by a triple-layer compression wrap. Healing was documented with digital photography and planimetry during weekly dressing changes. Wound closure was verified two weeks following initial closure documentation. All wounds demonstrated graft take one week after ASHC application. Ten out of 11 DFU patients (90.9%) had healed DFUs with a mean time to heal of 29.7 days (SD: 4.98; 95% CI: 19.9–39.4). At four weeks, the mean PAR for all 11 wounds was 83.1% (SD:31.3% CI: 14.4–35.6). One DFU patient developed a secondary infection not related to AHSC therapy requiring debridement and was withdrawn from the study 21 days after deployment. There were two AEs (18.1%), including one serious AE; neither was related to the study device or application procedure.

Conclusion: All wounds remained closed at two-week durability follow-up. All full-thickness skin donor harvest sites remained closed with minimal morbidity. AHSC successfully closed DFUs refractory to dressing care with a single application in this pilot study, warranting further evaluation with randomized controlled trials.