NCT03503370

Preventing Diabetic Foot Ulcers Through Cleaner Feet

Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DRUG	Chlorhexidine	Participants randomized to the intervention will wash their feet using 2% CHLORHEXIDINE GLUCONATE CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
DRUG	Placebo	Participants randomized to the placebo will wash their feet using COMFORT BATH CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.

Timeline

• Start date: 2019-01-02
• Primary completion: 2022-12-30
• Completion: 2023-01-06
• First posted: 2018-04-19
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

1 site across 1 country: United States