Diabetic Foot Ulcer Clinical Trial
Official title:
Treatment of Chronic Diabetic Foot Ulcers by Minimally Invasive Surgery in a Cross-sectional Study
Despite the development of the control of DM and the great interest for the complications of
the disease, even today the diabetic foot represents a challenge for the orthopaedic
surgeon. Being frequently correlated to alteration of the plantar pressures, the surgery
treatment is recommended and the Minimally Invasive Surgery (MIS) candidates itself to solve
this pathologic case.
The purpose of this longitudinal cross-sectional study was to evaluate radiographic and
surgical outcomes and the subjective grade of satisfaction of the patients with a diagnosis
of chronic plantar diabetic foot ulcers that have been treated at Padua's Orthopaedic Clinic
through MIS.
Thirty-two patients with chronic diabetic foot ulcers (CDFUs) were treated by MIS between January 2010 and September 2016. Clinical evaluation was assessed pre-operatively, as well as at 3 months after surgery and at final follow-up, using the American Orthopaedic Foot and Ankle Society (AOFAS) Hallux Metatarsophalangeal-Interphalangeal Scale. The recurrence of the ulcers and complications were recorded. All the ulcers were evaluated with the University of Texas Diabetic Wound Classification. We used the radiological Maestro's criteria to evaluated the radiographs before and after the operation. Also, the bridging bone/callus formation was evaluated at the different radiographic follow-ups, while the articular surface congruency. The global disability was evaluated with the Short Form Health Survey (SF-36) and the satisfaction's level with the Visual Analogue Scale (VAS). Statistical analysis was carried out using the Wilcoxon signed-rank test. Statistical significance was set at p < 0.05. ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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