Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota
Overview
- Phase
- Phase 2
- Intervention
- Chlorhexidine
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- VA Office of Research and Development
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Time to New Foot Complication Among All Randomized Participants
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults \>=18 years
- •Clinical diagnosis of diabetes
- •At high risk for a new diabetic foot ulcer due to: 1)Past history of diabetic foot ulcer or 2)Past history of major foot surgery including partial foot amputation or 3)Past history of major foot infection or 4)Neuropathy and onychomycosis and hemoglobin A1C \>8% or 5)Neuropathy and peripheral vascular disease or 6)Dialysis or 7)Past history of Charcot foot or 8)Past history of peripheral vascular surgery or angiography with stent
- •Two feet (can have amputation of part of the foot)
- •At least one foot without a foot ulcer
- •Permanent mailing address suitable for provision of specimen collection materials and telephone suitable for monthly follow-up
- •Able to give written informed consent
Exclusion Criteria
- •Amputation of the foot planned to treat current foot ulcer or wound
- •Current foot infection
- •Use of topical chlorhexidine on feet 7 days prior to randomization
- •History of an allergic reaction to chlorhexidine
- •Unable to use wipes for foot care
- •Inability to walk
- •Life expectancy less than 12 months
- •Plans to move out of the area in the next 13 months
- •Requires equivalent of institutional care (e.g. nursing home)
- •Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study
Arms & Interventions
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.
Intervention: Chlorhexidine
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Time to New Foot Complication Among All Randomized Participants
Time Frame: 12 months
Time in days to new foot complication (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to new foot complication; the results we are reporting are number of participants who developed a new foot complication in the 12 months post randomization). A new foot complication is defined as either 1) a new chronic (present 28 days from initial diagnosis) foot ulcer or wound or 2) a moderate or severe foot infection (as defined by IDSA Diabetic Foot Infection Severity classification: Table 2) not from an existing ulcer or 3) a foot amputation for a new ulcer.
Secondary Outcomes
- Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet(4 weeks after stopping the intervention (approximately 13 months after randomization))