Preventing Diabetic Foot Ulcers Through Cleaner Feet

NCT ID: NCT03503370

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2023-01-06

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

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chlorhexidine

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

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 Type: DRUG

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 Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary-Claire Roghmann, MD

Role: PRINCIPAL_INVESTIGATOR

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

Countries

United States

References

Lydecker AD, Kim JJ, Robinson GL, Johnson JK, Brown CH, Petruccelli CC, Terrin ML, Margolis DJ, Roghmann MC. Chlorhexidine vs Routine Foot Washing to Prevent Diabetic Foot Ulcers: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2460087. doi: 10.1001/jamanetworkopen.2024.60087.

Reference Type: DERIVED

PMID: 39964684 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INFB-015-17F

Identifier Type: -

Identifier Source: org_study_id