Flexor Tendon Tenotomy Treatment of the Diabetic Foot: A Multicenter Randomized Controlled Trial
Objective: The aim of this study was to evaluate effects of needle flexor tendon tenotomy treatment of the diabetic hammertoe deformity.
Research Design and Methods A multicenter randomized controlled trial of individuals with diabetes, and ulcers or impending ulcers associated with hammertoes, performed between 1st of November 2019 and 31st of March 2021. Participants were stratified on the presence of ulcer, into individuals with ulcers and individuals with impending ulcers. Participants were randomized to tenotomy and standard non-surgical treatment or standard non-surgical treatment alone. Primary outcomes were time to ulcer healing and progression from impending ulcer to active ulcer.
Results: Of 224 screened individuals with diabetes, 95 (59.0% male) were included. The mean follow-up was 291 (±70) days, 28 (29.5%) had type 1 diabetes, mean diabetes duration was 20 (13-26) years, and mean age was 67.7 (±9.8) years. Of the included participants 16 had ulcers, of whom eight were randomized to intervention. Of the remaining 79 individuals with impending ulcers, 39 were randomized to intervention.
For participants with ulcers, healing rates favored tenotomy (100% vs 37.5%, p=0.026) as did time to ulcer healing (p=0.04). For individuals with impending ulcers, incidence of progression to an active ulcer was lower (1 vs 7, p=0.028) and number of ulcer-free days were higher (p=0.043) in the tenotomy group. No serious adverse events were recorded.
Conclusion: This randomized study showed that the simple procedure of needle flexor tendon tenotomy was effective and safe when treating and preventing ulcers associated with the diabetic hammertoe deformity.