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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03503370
Other study ID # INFB-015-17F
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2, 2019
Est. completion date January 6, 2023

Study information

Verified date December 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 175
Est. completion date January 6, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Time to new foot complication among participants with a healed foot complication at randomization. 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. 12 months
Primary Time to new foot complication among all randomized participants 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. 12 months
Secondary Susceptibility to chlorhexidine among bacterial pathogens on the feet 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. 4 weeks after stopping the intervention
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