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Antiseptic

Chlorhexidine for Preventing Diabetic Foot Ulcers

Phase 2
Waitlist Available
Led By Mary-Claire Roghmann, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At high risk for a new diabetic foot ulcer due to past history of diabetic foot ulcer, past history of major foot surgery including partial foot amputation, past history of major foot infection, neuropathy and onychomycosis with hemoglobin A1C >8%, neuropathy and peripheral vascular disease, dialysis, past history of Charcot foot, or past history of peripheral vascular surgery or angiography with stent
Adults >=18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether using chlorhexidine to clean the feet each day can prevent diabetic foot ulcers from coming back.

Who is the study for?
This trial is for Veterans with diabetes who are at high risk of foot ulcers due to a history of such ulcers, major foot surgery, or other related conditions. Participants must be adults with two feet (partial amputations acceptable), able to consent, and have no current infections or life expectancy under 12 months.Check my eligibility
What is being tested?
The study tests if daily cleaning with chlorhexidine can prevent the recurrence of diabetic foot ulcers in individuals with a recent ulcer history. It's designed to see if this antiseptic approach is effective in maintaining cleaner and healthier feet.See study design
What are the potential side effects?
Potential side effects may include skin reactions like irritation or rash where chlorhexidine is applied. There's also a risk of allergic reactions for those sensitive to the antiseptic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a history of foot problems, high blood sugar, nerve or blood vessel issues, kidney dialysis, or certain foot surgeries that put you at high risk for getting a new diabetic foot ulcer.
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You are 18 years old or older.
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You do not have any open sores on at least one foot.
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You must have both feet, but it's okay if part of one foot is missing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to new foot complication among all randomized participants
Secondary outcome measures
Susceptibility to chlorhexidine among bacterial pathogens on the feet
Other outcome measures
Time to new foot complication among participants with a healed foot complication at randomization.

Side effects data

From 2020 Phase 2 trial • 44 Patients • NCT02252588
8%
Other oral side effects
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chlorhexidine
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ChlorhexidineExperimental Treatment1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorhexidine
2013
Completed Phase 4
~9050

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,604 Previous Clinical Trials
3,305,396 Total Patients Enrolled
5 Trials studying Foot Ulcer
977 Patients Enrolled for Foot Ulcer
Mary-Claire Roghmann, MDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 Previous Clinical Trials
261 Total Patients Enrolled

Media Library

Chlorhexidine (Antiseptic) Clinical Trial Eligibility Overview. Trial Name: NCT03503370 — Phase 2
Foot Ulcer Research Study Groups: Placebo, Chlorhexidine
Foot Ulcer Clinical Trial 2023: Chlorhexidine Highlights & Side Effects. Trial Name: NCT03503370 — Phase 2
Chlorhexidine (Antiseptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03503370 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants can the research team accept for this experiment?

"Unfortunately, applications for this trial are currently unavailable. The posting was initially made on 2nd January 2019 and last updated 10th of January 2022. If you're looking to apply elsewhere there is a considerable number of studies actively recruiting: 388 trials concerning diabetic foot syndrome and 21 clinical investigations related to Chlorhexidine usage are open at present."

Answered by AI

Does Chlorhexidine meet the standards of approval set forth by the FDA?

"Chlorhexidine is considered relatively safe, receiving a score of 2 on our scale. This medication has undergone some safety evaluation but efficacy data remains inconclusive at this point in time."

Answered by AI

Is this research initiative currently in the process of enrolling participants?

"Currently, this medical trial is not recruiting. It was first posted on 2nd January 2019 and last updated 10th January 2022. If you search for other studies related to diabetic foot, there are 388 trials currently admitting participants; similarly, 21 investigations utilizing chlorhexidine have available openings right now."

Answered by AI

What ailments can be treated with Chlorhexidine?

"Chlorhexidine is a popular antiseptic agent and has also been demonstrated to be successful in the disinfection of wounds, sore throats, and pressure ulcers."

Answered by AI
~28 spots leftby Mar 2025