(CR-047) Impact of a Nitric Oxide-generating Wound Dressing in Diabetic Foot Ulcers in Patients Receiving Antibiotics: Post-hoc Analysis

Chris Manu, MD FRCP – Consultant Diabetologist, Diabetic Foot Clinic, King’s College Hospital, UK; Alan Horner, PhD – Head of Translational Sciences, Medical and Clinical Affairs, Convatec; Michael Edmonds, MD – Professor, Consultant Physician, Consultant Diabetologist, Diabetic Foot Clinic, King’s College Hospital, UK

Introduction: Diabetic foot ulcers (DFUs) are a prevalent and serious complication of diabetes, which result in poor patient quality of life and substantial economic burden. Nitric oxide (NO) within a wound dressing represents a promising treatment for the management of DFUs, due to NO’s inherent antimicrobial properties. The purpose of this study was to evaluate the impact of a novel prototype NO-generating wound dressing*, compared with standard of care (SoC), on DFU wound healing in patients that were receiving antibiotics.

Methods: A post-hoc analysis of the ProNox 1 randomized controlled trial of a NO-generating wound dressing* compared to SoC was performed to determine the impact of NO-generating wound dressing* on DFU healing outcomes in patients receiving antibiotics at commencement and/or during the study. The study was conducted in 10 UK wound care centres, and primary endpoint analysis has been reported (Edmonds et al, 2018)¹. The primary efficacy measure of this post-hoc analysis was DFU percent area reduction (PAR) at 12 weeks. A secondary efficacy measure was number of DFUs completely healed at 12 weeks.

Results: Of the 135 patients in the study, 71 (53%; 34 in SoC group; 37 in NO-generating wound dressing* group) were treated with 29 different antibiotics. At final assessment, the mean PAR was 48.7% in NO-generating wound dressing*-treated wounds, compared to 19.8% in the SoC group; a 59% greater PAR in NO-generating wound dressing* group. The number of healed (100% PAR) DFUs in the NO-generating wound dressing* was 14/37 (38%) and in the SoC group was 9/34 (26%).

Discussion: This sub-analysis demonstrates the ability of a NO-generating wound dressing* to improve DFU healing outcomes in patients that we being treated with antibiotics, compared with SoC.