Mens M A, Busch-Westbroek T E, Bus S A, van Netten J J, Wellenberg R H H, Streekstra G J, Maas M, Nieuwdorp M, Kerkhoffs G M M J, Stufkens S A S
Amsterdam UMC, Location University of Amsterdam, Radiology and Nuclear Medicine, Meibergdreef 9, Amsterdam, the Netherlands.
Amsterdam Movement Sciences, Rehabilitation and Development, Amsterdam, the Netherlands.
Contemp Clin Trials Commun. 2023 Mar 11;33:101107. doi: 10.1016/j.conctc.2023.101107. eCollection 2023 Jun.
Foot ulcers are a frequent and costly problem in people with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformities are commonly seen in people with diabetes. These deformities increase the risk of ulcer development specifically at the (tip of) the toe. Percutaneous needle tenotomy of the tendon of the m. flexor digitorum longus (tendon tenotomy) can be used to reduce the severity of claw/hammer toe deformity with the goal to prevent ulcer recurrence. The main objective of this randomized controlled trial is to assess the efficacy of flexor tenotomy to prevent recurrence of toe ulcers in people with diabetes and a history of toe (pre-)ulcers. Additionally, we aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, barefoot plantar pressure during walking, cost-effectiveness and quality of life before and after the intervention and compare intervention and control study groups. Sixty-six subjects with diabetes and claw/hammer toe deformity and a recent history of (pre-)ulceration on the tip of the toe will be included and randomized between flexor tenotomy of claw/hammer toes (intervention) versus standard of care including orthosis and shoe offloading (controls) in a mono-center randomized controlled trial.
NCT05228340.
足部溃疡在糖尿病患者中是一个常见且代价高昂的问题，可能导致截肢。因此，预防这些溃疡至关重要。爪形趾/锤状趾畸形在糖尿病患者中很常见。这些畸形会增加特别是在脚趾（尖端）处发生溃疡的风险。长屈肌腱经皮针刺腱切断术（腱切断术）可用于减轻爪形趾/锤状趾畸形的严重程度，目的是预防溃疡复发。这项随机对照试验的主要目的是评估屈肌腱切断术对预防有脚趾（前）溃疡病史的糖尿病患者脚趾溃疡复发的疗效。此外，我们旨在评估负重和非负重位置的指间关节（IPJ）和跖趾关节（MTPJ）角度、行走时的赤足足底压力、干预前后的成本效益和生活质量，并比较干预组和对照组。在一项单中心随机对照试验中，将纳入66名患有糖尿病和爪形趾/锤状趾畸形且近期有脚趾尖端（前）溃疡病史的受试者，并将其随机分为爪形趾/锤状趾屈肌腱切断术（干预组）与包括矫形器和减轻鞋压力在内的标准护理（对照组）。
NCT05228340。
