Clinical Research

(CR-004) A multi-center, single-blinded randomized controlled clinical trial evaluating the effect of resorbable glass fiber matrix in the treatment of diabetic foot ulcers

Co-Author(s):

Dennis Orgill, MD, PhD; Robert Galiano, MD; Paul Glat, MD; Marissa Carter, PhD – Strategic Solutions; Lawrence Didomenico, DPM; Charles Zelen, DPM

Introduction: Diabetic foot ulcers (DFUs) when unresponsive to standard wound care, face serious risks of detrimental complications, including infection and amputation. A new novel, borate-based, bioactive glass nanofiber (BBGFM) has been introduced for treatment of complex wounds including DFU’s. The primary objective of our study was to further investigate the healing potential of this unique nanofiber in subjects with chronic DFUs and comparing the healing rate to treatment with Standard of Care (SOC) alone. Methods: Forty patients with non healing diabetic foot wounds at least 1.0 cm in size, with adequate blood flow, and no associated renal failure were randomized to receive either Standard of care (SOC, Collagen alginate) alone or application of the BBGFM and treated for a period of 12 weeks. Both groups received standard diabetic foot care including glucose monitoring, weekly debridement’s when needed and an offloading device. The primary endpoint was proportion of full-thickness, non-infected, non-ischemic wounds healed at 12 weeks, with secondary endpoints including percent area reduction (PAR) and changes in Semmes-Weinstein monofilament testing. Results: <span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-theme-font: minor-latin; color: #1c1d1e; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">The result illustrated in the intent-to-treat analysis at 12 weeks showed that 70% (14/20) of the BBGFM-treated DFUs healed compared with 25% (5/20) treated with SOC alone (adjusted P = .006). Mean PAR at 12 weeks was 79% in the BBGFM group compared with 37% in the SOC group (adjusted P = .027). Mean change in neuropathic score between baseline and up to 12 weeks of treatment was 2.0 in the BBGFM group compared with −0.6 in the SOC group where positive improvement in scores are better (adjusted P = .008). The mean number of BBGFM applications was 6.0 Discussion: <span style="font-size: 11.0pt; line-height: 107%; font-family: 'Calibri',sans-serif; mso-ascii-theme-font: minor-latin; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-theme-font: minor-latin; color: #1c1d1e; background: white; mso-ansi-language: EN-US; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">Adding BBGFM to a standard diabetic foot care regimen significantly improved wound healing with no adverse events related to treatment compared with SOC alone Trademarked Items: Mirragen Wound Matrix (ETS Wound Care, Rolla MO) References: