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1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer
2. Research design and methods: Forty-five adult diabetic patients with non-ischemic, non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment duration was 90 days. Percent reduction in ulcer surface area and total healing rates were evaluated after treatment.
Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan, Italy) participated to this open, randomized clinical trial. The ethics-committee approved the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and ended March 2009. Eligible patients were fully informed of the study aim and procedures and written consent was obtained prior to study participation. Patients were then randomly assigned to one of the two treatment groups by opening randomization codebreak envelopes containing one of the two options. Separate randomization was performed for each center, and a copy of all randomization envelopes was kept at the statistical department of the Multimedica center. The two arms were composed of patients managed with non-removable fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
non-removable fiberglass, Stabil-D®
Diabetic Foot Center - IRCCS Multimedica
Sesto San Giovanni
Published on BioPortfolio: 2014-08-27T03:18:16-0400
The purpose of this study was to determine if insoles with removable pegs could effectively reduce the plantar aspect pressure with the aid of in-shoe plantar pressure analysis for guidanc...
100 consenting subjects with Texas grade 1a diabetic foot ulcers will be randomized to surgical offloading or non-operative offloading.
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Foot ulcers affect 15% of patients with diabetes, resulting in a great health burden. The occurrence and development of diabetic foot ulcers is associated with neuropathy, peripheral arterial disease,...
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To determine the relationship between eNOS uncoupling and diabetic ischemic foot and whether reversing eNOS uncoupling by Dihydrofolate reductase (DHFR) transfection or folic acid (FA) supplementation...
Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.
Dressings made of fiberglass, plastic, or bandage impregnated with plaster of paris used for immobilization of various parts of the body in cases of fractures, dislocations, and infected wounds. In comparison with plaster casts, casts made of fiberglass or plastic are lightweight, radiolucent, able to withstand moisture, and less rigid.
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Devices used to support or align the foot structure, or to prevent or correct foot deformities.
Distortion or disfigurement of the foot, or a part of the foot, acquired through disease or injury after birth.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Bioethics is the study of controversial ethics brought about by advances in biology and medicine. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philo...