Complete wound closure following a single topical application of a novel autologous homologous skin construct: first evaluation in an open-label, single-arm feasibility study in diabetic foot ulcers

Abstract

Diabetic foot ulcers (DFUs) are a growing burden on patients and health care systems that often require multiple treatments of both conventional and advanced modalities to achieve complete wound closure. A novel autologous homologous skin construct (AHSC) has been developed to treat cutaneous defects with a single topical application, by leveraging the endogenous repair capabilities of the patient's healthy skin. The AHSC's ability to close DFUs with a single treatment was evaluated in an open-label, single-arm feasibility study. Eleven patients with DFUs extending up to tendon, bone, or capsule received a single topical application of AHSC. Closure was documented weekly with high-resolution digital photography and wound planimetry. All 11 DFUs demonstrated successful graft take. Ten DFUs closed within 8 weeks. The median time-to-complete closure was 25 days. The mean percent area reduction for all 11 wounds at 4 weeks was 83%. There were no adverse events related to the AHSC treatment site. This pilot study demonstrated AHSC may be a viable single application topical intervention for DFUs and warrants investigation in larger, controlled studies.

Keywords: autologous homologous skin construct; diabetic foot ulcer; novel therapy; wound healing.

Conflict of interest statement

The Professional Education and Research Institute, for which Medical Director Charles Zelen DPM, received research support from PolarityTE to administer this study.

The Surgery Department for the University of Southern California has received research funds from PERI provided by PolarityTE for D.G.A. to serve as principal investigator and assist in completion of this study and is assisting in the completion of the DFU RCT. D.P.O. is a consultant for PERI and has received funds from PERI to assist in completion of this study and in the completion of the DFU RCT. P.M.G., PC for which P.M.G. is the Medical Director and owner has received research funds from PERI provided by PolarityTE to assist in completion of this study and is assisting in the completion of the DFU RCT. R.G. is a consultant for PERI and has received research funds from PERI provided by PolarityTE to assist in completion of this study and is assisting in the completion of the DFU RCT. M.C. is a consultant for PERI and has received funds from PERI to assist in completion of this study and perform the statistical analysis. The Professional Education and Research Institute (PERI), for which C.M.Z. is medical director and CEO has received research funds from PolarityTE to conduct this study and is assisting in the completion of the DFU RCT. LLC for which W.W.L. is the Medical Director and owner has received research funds from PERI provided by PolarityTE to assist in completion of this study, serve as medical monitor and is assisting in the completion of the DFU RCT.

© 2020 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Figures

FIGURE 1

Diagram of events during the harvest and application of autologous homologous skin construct (AHSC). A 2 × 1 cm piece of healthy tissue was harvested from the proximal calf of each patient in the office. This was shipped overnight to an FDA‐registeredbio‐manufacturing facility, where it was processed into AHSC. It was returned to the provider the following day. The AHSC was deployed on the debrided wound bed on the third day in the clinic. FDA, U.S. Food and Drug Administration

FIGURE 2

Representative images of Patient No. 3, an 82‐year‐old man with diabetes, hypertension, neuropathy, gout, arthritis, and glaucoma, who presented with a 2 cm2 diabetic foot ulcer (DFU) on the left, plantar, medial, forefoot; Patient No. 4, a 56‐year‐old man with diabetes, hypertension, hyperlipidemia, gastroesophageal reflux disease, and neuropathy and a previous amputation of the hallux, who presented with a 3 cm2 DFU on the right, plantar, medial, forefoot; Patient No. 5, a 78‐year‐old woman with diabetes, hypertension, hyperlipidemia, gastroesophageal reflux disease, neuropathy, hypothyroidism, depression, and venous leg ulcer, who presented with a 1 cm2 DFU on the first digit toe of the left foot; and Patient No. 7, a 48‐year‐old woman with diabetes, hyperlipidemia, gastroesophageal reflux disease, neuropathy, chronic kidney disease, and heart disease, who presented with a 22 cm2 DFU on the right, plantar, medial, heel

FIGURE 3

Kaplan–Meier graph of the time to closure

FIGURE 4

Images of Patient No. 6, a 53‐year‐old woman who was treated for a 5 cm2 left plantar lateral heel diabetic foot ulcer (DFU) and was withdrawn from the study following an infection of the study foot of indwelling hardware from a prior Charcot foot reconstruction procedure. A, Pretreatment wound; B, ASHC applied; C, interim closure 13‐days following treatment; D, development of infected left lateral wound related to prior Charcot foot reconstruction requiring surgical intervention