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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
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.
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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 COMFORT BATH CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
  • 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.

More Details

Status
Completed
Sponsor
VA Office of Research and Development

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.