Noninferiority of Copper Dressings Than Negative Pressure Wound Therapy in Healing Diabetic Wounds: A Randomized Clinical Trial.

Abstract

Objective: To evaluate if treatment of diabetic wounds by copper oxide impregnated dressings (COD) is noninferior to negative pressure wound therapy (NPWT). Approach: Following the CONSORT guidelines, patients with diabetes mellitus (type 1 or type 2) and noninfected wounds eligible for treatment with NPWT were randomized into two groups. One group received NPWT followed by standard wound care dressings, whereas the other was treated exclusively with COD. The primary outcome was wound size reduction, measured blindly using a 3D wound-imaging system. Secondary outcomes included patient and caregiver convenience (assessed via visual analog scores), cost, and additional wound parameters. Results: COD showed statistically significant noninferiority to NPWT in wound size reduction throughout the study (p < 0.01). The percentage of wounds that closed was 47.83% (11/23) and 34.78% (8/23) in the COD and NPWT arms, respectively (p > 0.05). The average time to wound closure, adjusted to potential confounders, such as gender, age, body mass index, diabetes, and smokers, was similar in both arms (p > 0.05). COD were found to be more convenient than NPWT for both patients (p < 0.001) and caregivers (p = 0.003), with a significantly shorter application time (p < 0.001). The COD cost was 14% of NPWT cost ($470 compared with $3,360). Innovation: COD may be considered as the first line of treatment for diabetic foot wounds when NPWT seems indicated. Conclusions: Using copper dressings as a first line of treatment of diabetic wounds, when NPWT is indicated, is expected to reduce health costs, improve convenience, and increase compliance without compromising the final outcome.