Preventing Diabetic Foot Ulcers Through Cleaner Feet

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT03503370

Collaborator

(none)

175

Enrollment

Location

Arms

59.9

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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 recurrence of diabetic foot ulcers in Veterans with a recent history of a foot ulcer.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcer	Drug: Chlorhexidine	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

175 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota

Actual Study Start Date :

Jan 2, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: 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 Comparator: placebo 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 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.

Arm

Intervention/Treatment

Experimental: 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: Chlorhexidine

Placebo Comparator: placebo

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

Outcome Measures

Primary Outcome Measures

Foot complications [12 months]
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 a foot amputation for a new ulcer.

Secondary Outcome Measures

Susceptibility to chlorhexidine and other antibiotics among bacterial pathogens [4 weeks after stopping the intervention]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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