The efficacy of removable devices to offload and heal neuropathic plantar forefoot ulcers in people with diabetes: a single-blinded multicentre randomised controlled trial

Non-removable offloading is the 'gold standard' treatment for neuropathic diabetic plantar forefoot ulcers. However, removable offloading is the common 'standard of care'. We compared three removable offloading devices for ulcer healing efficacy. In this multicentre, randomised controlled trial, 60 persons with neuropathic diabetic plantar forefoot ulcers were randomly assigned to wear a custom-made knee-high cast [BTCC (bivalved TCC)], custom-made ankle-high cast shoe or a prefabricated ankle-high forefoot-offloading shoe (FOS). Primary outcome was healing at 12 weeks. Dynamic plantar pressures, daily stride count and treatment adherence were assessed on a randomly selected subset (n = 35). According to intention-to-treat analysis, 58% of patients healed with BTCC [OR 0·77 (95% CI 0·41-1·45) versus FOS], 60% with cast shoe [OR 0·81 (95% CI 0·44-1·49) versus FOS] and 70% with FOS (P = 0·70). Mean ± SD peak pressure in kPa at the ulcer site was 81 ± 55 for BTCC, 176 ± 80 for cast shoe and 107 ± 52 for FOS (P = 0·005); stride count was 4150 ± 1626, 3514 ± 1380 and 4447 ± 3190, respectively (P = 0·71); percentage of 2-week intervals that patients wore the device <50% of time was 17·3%, 5·2% and 4·9%, respectively. Non-significant differences in healing efficacy between the three devices suggest that, when non-removable offloading is contraindicated or not available, each can be used for plantar forefoot ulcer offloading. Efficacy is lower than previously found for non-removable offloading maybe because suboptimal adherence and high stride count expose the patient to high repetitive stresses. These factors should be carefully considered in decision making regarding ulcer treatment.