Background Ray amputation is commonly performed for irretrievable digital infections and/or ischemia, particularly in diabetic foot disease. Re-ulceration and reoperation rates after toe amputation range from 43-65%. Numerous studies have investigated patient-dependent factors of wound healing, including diabetes, malnutrition, smoking, and renal failure. However, there has been minimal research on the impact of technical surgical factors on patient outcomes. Methods This protocol describes a single-center, prospective, randomized controlled, assessor-blinded feasibility study comparing outcomes after ray amputation between two accepted methods: metatarsal transection, manual bone cutter (BC), or an oscillating microsaw (OS). The inclusion criteria were adults undergoing toe amputation via metatarsal transection capable of providing informed consent. The exclusion criteria were significant peripheral arterial disease (ABPI <0.4) and en bloc resection of three or more toes. Participants will be allocated to one of two parallel groups in a 1:1 fashion using randomization by minimization, stratifying for chronic kidney disease (eGFR <60 mL/min/1.73 m2) and palpable pulses. The primary objective was to gather sufficient data to accurately power a future definitive trial. Secondary outcomes included differences between the two trial arms in re-operation and readmission rates at six months, time to wound healing post-index procedure, and patient-reported postoperative pain scores. Ethical approval was granted for recruitment in January, 2023. Discussion We hypothesized that an OS reproducibly achieves a smoother and more precise cut and produces less bony debris to act as an infective nidus with minimal inter-surgeon variation. Due to a lack of guiding evidence, surgeon preference for ray amputation technique evolves from the ‘apprenticeship’ training model, personal experience, and local equipment availability. We aimed to provide robust data to guide decision-making as the incidence of diabetes increases and the number of minor amputations increases. Trial Registration ClinicalTrials. gov registration NCT05804565 on 26/03/2023
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