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.

Full-text preview

Available from:
  • Source

    Full-text · Article · Mar 2013 · Endocrine
  • [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%.
    No preview · Article · Sep 2013 · The Medical clinics of North America
  • [Show abstract] [Hide abstract]
    ABSTRACT: Throughout the United States, government and private payers are exploring new payment models such as accountable care organizations and shared savings agreements. These models are widely based on the construct of the Triple Aim, a set of three principles for health services reform: improving population-based outcomes, improving patient care experiences, and reducing costs through better delivery systems. Wound programs may adapt to the new health financing environment by incorporating initiatives known to promote the Triple Aim, such as diabetes amputation reduction and pressure ulcer prevention programs, and by rethinking how health services can best be delivered to meet these new criteria. The existing literature supports that programmatic approaches can improve care, quality, and cost, especially in the field of diabetic foot ulcers. Wound healing programs have opportunities to develop new business plan models that provide quality, cost-efficient care to their patient population and to be leaders in the development of new types of partnerships with payers and health delivery organizations.
    No preview · Article · Oct 2013 · Ostomy/wound management
Show more