Abstract
The aim of this multicenter, prospective, observer-blinded, parallel group, randomized controlled trial was to assess the safety and efficacy of EDX110, a nitric oxide generating medical device, in the treatment of diabetic foot ulcers in a patient group reflecting "real world" clinical practice compared against optimal standard care. Participants were recruited from ten hospital sites in multidisciplinary foot ulcer clinics. The ulcers were full thickness, with an area of 25-2,500 mm2 and either a palpable pedal pulse or ankle brachial pressure index > 0.5. Infected ulcers were included. Treatment lasted 12 weeks, or until healed, with a 12-week follow-up period. Both arms were given optimal debridement, offloading and antimicrobial treatment, the only difference being the fixed used of EDX110 as the wound dressing in the EDX110 group. 135 participants were recruited with 148 ulcers (EDX110-75; Control-73), 30% of which were clinically infected at baseline. EDX110 achieved its primary endpoint by attaining a median Percentage Area Reduction of 88.6% compared to 46.9% for the control group (p = 0.016) at 12 weeks in the intention-to-treat population. There was no significant difference between wound size reduction achieved by EDX110 after 4 weeks and the wound size reduction achieved in the control group after 12 weeks. EDX110 was well tolerated. Thirty serious adverse events were reported (12 in the EDX110 group, of which 4 were related to the ulcer; 18 in the control group, of which 10 were related and 1 possibly related to the ulcer), with significant reduction in serious adverse events related to the ulcer in EDX group. There was no significant difference in adverse events. This study, in a real world clinical foot ulcer population, demonstrates the ability of EDX110 to improve healing, as measured by significantly reducing the ulcer area, compared to current best clinical practice.
Highlights
Patients with diabetes have a lifetime incidence of up to 25% for developing diabetic foot ulcers (DFUs).[1]
This multicenter, prospective, observer blinded, randomized controlled trial has shown that treatment of diabetic foot ulcers with EDX110 was safe and well tolerated
The percentage ulcer area reduction from baseline (PAR) at 12 weeks was significantly improved in the EDX110 group compared with the control group
Summary
Patients with diabetes have a lifetime incidence of up to 25% for developing diabetic foot ulcers (DFUs).[1]. The lack of an evidence base for advanced wound dressings to manage DFUs was widely acknowledged.[5,6] Each of the available guidelines for the treatment of DFU recommends debridement, pressure offloading, and an ‘appropriate’ dressing,[5,7] and it is commonly stated there is little difference in efficacy between the many dressings in current use and a lack of robust data.[3,5,6,7,8] Of note, some RCTs, useful in establishing efficacy under ideal circumstances for a variety of wound-healing interventions, do not provide the necessary information to establish effectiveness in the “usual” compromised wound center patient.[9] The critical factors determining non-healing status of DFUs are ischemia and/or infection.[10] Nitric oxide (NO) plays a crucial role in maintaining the microvascular supply and infection control in the skin, and its absence in diabetes is a compounding factor in poor ulcer healing.[11,12] The role of NO in ulcer healing involves three recognized elements: vascular, as NO influences blood vessel vasodilatation and stimulates angiogenesis;[13,14] inflammatory, as NO influences the host immune response;[15] and antimicrobial as NO demonstrates potent, broad spectrum antimicrobial activity.[16] EDX110 (Edixomed, London, UK) is a two-layer system designed to generate NO in-situ. The aim of this study, ProNOx1, was to assess the safety and efficacy of EDX110, a Class III medical device, compared to standard of care (SOC) dressings - the control group - in the treatment of diabetic foot ulcers with a wide inclusion criteria to reflect the population in which EDX110 would inevitably be used if the study was successful
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