Use of a Novel Human Keratin Matrix Improves Healing Rates in Diabetic Lower Extremity Wounds

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Background. Lower extremity wounds in patients with diabetes are difficult to heal due to an overabundance of pro-inflammatory M1 macrophages, reduced phagocytosis of necrosed cells, and circulatory issues. Keratin biomaterials have been shown to address some of these concerns by encouraging the proliferation of anti-inflammatory M2 macrophages, thereby creating more favorable conditions for wound healing resembling those of patients without diabetes. Objective. To investigate the effect of a novel human keratin matrix (HKM) on wound healing. Materials and Methods. Ten patients with diabetes with lower extremity wounds at risk for delayed healing underwent wound debridement and application of HKM. Patients received weekly follow-up care and reapplication of HKM until healing occurred; wound size at each visit was used to calculate healing rate. Results. Increased healing rates were noted with HKM compared with standard of care (SOC), including debridement and collagen treatment in all 8 patients who had received SOC prior to HKM treatment. When HKM treatment was alternated with SOC in 2 patients due to other medical conditions, healing rates decreased with SOC and then increased after reintroduction of HKM applications. Conclusions. These results suggest that HKM may help regulate the pathological processes that contribute to wound chronicity to “kick-start” wound healing. This case series demonstrates that HKM is a promising technology to improve healing rates in nonhealing lower extremity wounds in patients with diabetes.