A novel approach for the treatment of diabetic foot ulcers using a multimodal wound matrix: a clinical study.

Innovation in wound healing, particularly regarding diabetic foot ulcers (DFUs), is needed to reverse the number of diabetes-related amputations. This study evaluated a novel approach and performance of a multimodal wound matrix in converting stalled DFUs into a healing trajectory. Patients with either type 1 or 2 diabetes and with foot ulcers (Wagner grade 1 and 2), were screened to determine eligibility for treatment. Ulcers improving >30% in area during a two-week screening phase were not eligible for the study treatment phase. The study was an open-label trial conducted in three phases: screening, treatment and healing confirmation. Patients enrolled in the study received a treatment protocol that included application of a wound matrix to the ulcer and offloading. A total of 19 patients (15 males, four females) with a median age of 60 years, and a median ulcer duration of 36 weeks took part in the study. Patients showed an average four-week percentage area reduction (PAR) of 62%, a 12-week PAR of 94%, and a 12-week healing rate of 57% (8/14). Results of this study support the viability and potential of a novel approach to treating DFUs that includes use of a multimodal wound matrix.