Preventing Diabetic Foot Ulcers Through Cleaner Feet

Study Overview
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Brief Summary
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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 recurrence of diabetic foot ulcers in Veterans with a recent history of a foot ulcer.

Detailed Description
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Population: Up to 200 Veterans at risk for diabetic foot ulcer recurrence 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 recurrence 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

Official Title
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Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: Chlorhexidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single center, randomized, double blind (participant, outcome assessor), parallel group clinical trial comparing daily foot care with cloths containing 2% chlorhexidine compared to daily foot care with cloths not containing chlorhexidine.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chlorhexidine<br>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: Chlorhexidine<br>* 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.<br>|
| Placebo Comparator: placebo<br>Participants randomized to the placebo will wash their feet using bath CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer. | Drug: Chlorhexidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot complications | The investigators will assess participants for foot complications to include: new chronic foot ulcers or foot infections or foot amputations. The primary outcome is either 1) a new chronic (present 28 days from initial diagnosis) foot ulcer or a moderate or severe foot infection (as defined by IDSA Diabetic Foot Infection Severity classification) not from an existing ulcer 3) a foot amputation for a new ulcer. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Susceptibility to chlorhexidine and other antibiotics among bacterial pathogens | Susceptibility to chlorhexidine and other antibiotics among bacterial pathogens. Participants will have cultures performed with a nylon flocked swab at enrollment and at 13 months approximately 4 weeks after stopping the intervention. | 4 weeks after stopping the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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topical chlorhexidine, prevention, clinical trial