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Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot ulcer, which became infected. This is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the occurrence of diabetic foot ulcers in Veterans at high risk of a diabetic foot ulcer.
Full description
Population: Up to 200 Veterans at high risk of a diabetic foot ulcer
Site: VA Maryland Health Care System (VAMHCS)
Study Duration: Approximately 5 years
Study Design: Randomized double-blind clinical trial comparing a) a daily foot care regimen with cloths containing 2% chlorhexidine to b) a daily foot care regimen with cloths not containing 2% chlorhexidine
Objectives:
Primary: To determine if chlorhexidine reduces the occurrence of foot complications including chronic foot ulcer, foot infection or foot amputation.
Secondary: To determine if chlorhexidine increases antibiotic resistance among bacterial pathogens on feet.
Exploratory: To describe changes in the microbiota of the feet with chlorhexidine and foot complications
Treatment Regimens: 2% Chlorhexidine Gluconate Cloths versus Bath Cloths
Route of Administration: Topical application on the feet
Dose and Interval: 1 cloth daily
Duration of Participant's Participation: Up to 13 months
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175 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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