Custom-Made Orthesis and Shoes in a Structured Follow-Up Program Reduces the Incidence of Neuropathic Ulcers in High-Risk Diabetic Foot Patients

University of Pisa, Pisa, Italy.
The International Journal of Lower Extremity Wounds (Impact Factor: 0.93). 02/2012; 11(1):59-64. DOI: 10.1177/1534734612438729
Source: PubMed


The objective of this study was to assess the impact of a structured follow-up program on the incidence of diabetic foot ulceration (DFU) in high-risk diabetic patients.
A total of 1874 diabetic patients referred to the Diabetic Foot Unit of the University of Pisa were ranked based on the ulcerative risk score proposed by the International Consensus on Diabetic Foot. Out of 334 patients (17.8%) with a score ≥2, 298 accepted to participate in this prospective trial and were randomized into 2 groups: group A, which received standard treatment, and group B, in which the patients received, as a part of a structured prevention program, custom-made orthesis and shoes. Incidence of new DFUs was observed for no less than 1 year and in a subset of patients after 3 and 5 years, respectively. Incidence of new DFUs and recurrences were considered as primary endpoints to establish the effectiveness of the program; costs were also compared.
Among the patients enrolled in this follow-up analysis, 46% had neuropathy and deformities, 20% had previous ulceration, 25% had previous minor amputation, and 9% had neuro-osteoarthropathy. During the first 12-month follow-up, 11.5% of patients in group B developed a DFU compared with 38.6% in group A (P < .0001). In the extended follow-up, the cumulative incidence of ulcer in group B compared with group A was 17.6% versus 61% (P < .0001) after 3 years and 23.5% versus 72% (P < .0001) after 5 years, respectively. The net balance at the end of the follow-up was highly in favor of the prevention program, with a saving of more than €100 000 per year.
The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabetic patients who are at high ulcerative risk and its related costs.

34 Reads
  • Source
    Endocrine 03/2013; 44(1). DOI:10.1007/s12020-013-9929-7 · 3.88 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Prevention is overlooked and underused, even in very high-risk patients. Prevention is best achieved within a multispecialty group of providers that have a common objective. Ideally, the team approach should include educators; physical therapists; nurses; internist; pedorthists; and vascular, orthopedic, and podiatric surgeons. The basic elements involve education, foot examination, risk classification, therapeutic shoes and insoles, and regular foot care. High-risk patients need additional assessment for vascular disease and intensive disease management, and corrective vascular and foot surgery when necessary. Basic interventions can reduce the incidence of foot ulcers by more than 50%.
    The Medical clinics of North America 09/2013; 97(5):807-20. DOI:10.1016/j.mcna.2013.05.001 · 2.61 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: OBJECTIVE Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence.RESEARCH DESIGN AND METHODS We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken.RESULTSOn the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045).CONCLUSIONS Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.
    Diabetes care 10/2013; 36(12). DOI:10.2337/dc13-0996 · 8.42 Impact Factor
Show more


34 Reads
Available from