The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial

• Published in: Contemporary clinical trials communications Vol. 33; p. 101107
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01-06-2023; Elsevier
• Subjects: Flexor tenotomy; Foot ulcer; Prevention; Toe deformity; IPJ; RCT; Flexor tenotomy; MTPJ; WTBCT; DM; Toe deformity; ROI; CBCT; SF-36; Prevention; SD; μSv; Foot ulcer; PIPJ; DIPJ; PIPJ, Proximal Interphalangeal Joint; WTBCT, Weight-Bearing CT; IPJ, Interphalangeal Joint; DM, Diabetes Mellitus; DIPJ, Distal Interphalangeal Joint; μSv, Microsievert; MTPJ, Metatarsal Phalangeal Joint; SD, Standard Deviation; CBCT, Cone-Beam Computed Tomography; RCT, Randomized Controlled Trial; SF-36, Short-Form-36; ROI, Region Of Interest
• ISSN: 2451-8654; 2451-8654
• DOI: 10.1016/j.conctc.2023.101107

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.