Case Series: Treatment with a Human Keratin Hydrogel Matrix* Improves Clinical Outcomes in Non-Healing Foot Ulcer Patients

Background: Non-healing extremity wounds such as foot ulcers pose severe and costly risks to patients, including hospitalization, infection, and amputation. Such wounds often arise on patients with comorbidities that affect circulation, such as mobility and vascular impairments. Many products aim to treat and heal chronic wounds, but severe foot ulcers may still not respond to these treatments. Human keratin-derived wound dressings are a novel material approach in this application, utilizing proteins similar to those found in skin to promote wound healing.

Purpose: This case series investigated the efficacy of a novel human keratin hydrogel matrix* (HKHM) in nine patients with foot ulcers that did not respond to or did not fully close after treatment with non-keratin based wound dressing products (e.g. amniotic membrane).

Methods: Patients in this case series ranged in age from 38 to 81, and had chronic comorbidities related to their wounds such as diabetes, obesity, and hypertension. Foot ulcers that previously did not heal with a non-keratin wound dressing material were treated weekly with HKHM* after debridement of the wound area and treatment with antibiotics, when necessary. Wound size was measured and photographed weekly after debridement, and fresh dressings were applied until full wound closure.

Results: Presence of granulation tissue, neovascularization, and new epithelial tissue was observed after only 1 application of HKHM*. At least 6 patients experienced full wound closure with 4 weeks of treatment with HKHM*, with three ongoing treatments showing reduced wound size after the first application.

Conclusions: Many common conditions can inhibit wound healing, creating a clinical need for treatments to address foot ulcers and other “hard-to-heal” wounds before severe complications occur. Patients with chronic foot wounds that were not responsive to other biopolymer matrix materials showed improved healing when treated with HKHM*. The use of keratin-based products may be beneficial for complex patients with non-healing wounds and multiple co-morbidities that do not respond to other treatments.