Preventing Diabetic Foot Ulcers Through Cleaner Feet

Phase 2

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Chlorhexidine	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.

Primary Outcome Measures

Name	Time	Method
Time to New Foot Complication Among All Randomized Participants	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 Outcome Measures

Name	Time	Method
Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet	4 weeks after stopping the intervention (approximately 13 months after randomization)	Susceptibility to chlorhexidine among bacterial pathogens on the feet. Chlorhexidine minimum inhibitory concentration (MIC) values were normalized across pathogens by subtracting the median MIC value (MIC50) from the literature for each pathogen from the observed MIC value on a log2() scale. The results we are reporting are the mean normalized MIC values and the Wilcoxon Rank Sum test comparing the difference in distribution of normalized MIC values. Effect size is expressed in means as this is more sensitive to group differences than the median. The possible range for the normalized observed MIC values on a log2() scale is from -8 to 8 with a higher value indicating that the pathogens collected were more resistant to chlorhexidine as compared to the median MIC values reported in the literature.