Rizzo L, Tedeschi A, Fallani E, Coppelli A, Vallini V, Iacopi E, Piaggesi A, et al.
The international journal of lower extremity wounds. Date of publication 2012 Mar 1;volume 11(1):59-64.
1. Int J Low Extrem Wounds. 2012 Mar;11(1):59-64. doi: 10.1177/1534734612438729.
Epub 2012 Feb 15.
Custom-made orthesis and shoes in a structured follow-up program reduces the
incidence of neuropathic ulcers in high-risk diabetic foot patients.
Rizzo L(1), Tedeschi A, Fallani E, Coppelli A, Vallini V, Iacopi E, Piaggesi A.
Author information:
(1)University of Pisa, Pisa, Italy.
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.
DOI: 10.1177/1534734612438729
PMID: 22336901 [Indexed for MEDLINE]
