OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: 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 diabeticpatients. RESEARCH DESIGN AND METHODS: A total of 1874 diabeticpatients 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. RESULTS: 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. CONCLUSIONS: The implementation of a structured follow-up with the use of orthesis and shoes can reduce the incidence of DFU in diabeticpatients who are at high ulcerative risk and its related costs.
Authors: Fay Crawford; Francesca M Chappell; James Lewsey; Richard Riley; Neil Hawkins; Donald Nicolson; Robert Heggie; Marie Smith; Margaret Horne; Aparna Amanna; Angela Martin; Saket Gupta; Karen Gray; David Weller; Julie Brittenden; Graham Leese Journal: Health Technol Assess Date: 2020-11 Impact factor: 4.014
Authors: Stephen J Preece; Jonathan D Chapman; Bjoern Braunstein; Gert-Peter Brüggemann; Christopher J Nester Journal: J Foot Ankle Res Date: 2017-07-06 Impact factor: 2.303
Authors: Sicco A Bus; Roelof Waaijman; Mark Arts; Mirjam de Haart; Tessa Busch-Westbroek; Jeff van Baal; Frans Nollet Journal: Diabetes Care Date: 2013-10-15 Impact factor: 19.112