CLINICAL TRIAL

Chlorhexidine for Foot Ulcer

High Risk
Waitlist Available · 18+ · All Sexes · Baltimore, MD

This study is evaluating whether a topical antiseptic may help prevent foot ulcers from recurring in veterans with diabetes.

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About the trial for Foot Ulcer

Eligible Conditions
Ulcer · Foot Ulcer · Diabetic Foot · Diabetic Foot Ulcers (DFUs)

Treatment Groups

This trial involves 2 different treatments. Chlorhexidine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Chlorhexidine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Chlorhexidine
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorhexidine
FDA approved

Side Effect Profile for Chlorhexidine

Chlorhexidine
Show all side effects
8%
Other oral side effects
0%
Congestion, Sinus Infection, and Cough
0%
Irritation and/or sores of the lining of the mouth
Other oral side effects
8%
Congestion, Sinus Infection, and Cough
0%
Irritation and/or sores of the lining of the mouth
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02252588) in the Chlorhexidine ARM group. Side effects include: Other oral side effects with 8%, Congestion, Sinus Infection, and Cough with 0%, Irritation and/or sores of the lining of the mouth with 0%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
placement High risk for a new diabetic foot ulcer due to neuropathy and onychomycosis and hemoglobin A1C >8%. show original
A permanent mailing address that is suitable for specimen collection materials and a telephone number that is suitable for monthly follow-up are both necessary. show original
If you have lost part of your foot, you can still wear a prosthesis on your remaining foot. show original
The text states that a person is able to give written consent if they are able to understand the implications of the consent form. show original
Adults >=18 years
A clinical diagnosis of diabetes is reached when a person has diabetes symptoms and blood tests confirms the diagnosis show original
at the end of the study At least one foot without a foot ulcer at the end of the study period. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Chlorhexidine will improve 1 primary outcome and 1 secondary outcome in patients with Foot Ulcer. Measurement will happen over the course of 4 weeks after stopping the intervention.

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.
4 WEEKS AFTER STOPPING THE INTERVENTION
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.
12 MONTHS

Patient Q & A Section

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

What are the signs of foot ulcer?

Signs of foot ulcer include sudden appearance or onset of pain in a foot or ankle with at least one of the following: erythema, edema, or discharge of pus. Chronic foot ulcers can be symptomatic if erythema, edema or discharge are present. The presence of foot ulcers is a key factor at presentation in patients with diabetes.

Anonymous Patient Answer

Can foot ulcer be cured?

This is one area of a chronically high rate of chronic foot problems. A foot ulceration may disappear on admission to the hospital with no further intervention in a period of several weeks. This is a high incidence of nonhealing chronic foot ulceration which affects millions of people globally.

Anonymous Patient Answer

What causes foot ulcer?

Nearly half of the ulcer cases were of unknown cause. The foot has many natural hazards such as overuse of footwear, prolonged inactivity or disability, and chronic venous insufficiency which can all lead to ulcer formation. Other factors associated with poor ulcer recurrence rates are age, size of ulcer, duration of ulcer, presence of a granulation tissue, and underlying diabetes. A low recurrence rate depends not only upon foot care but also good wound healing. It can be difficult to accurately diagnose the cause of ulcer due to the long delay between first symptoms to treatment initiation. There may be significant benefit from research into ulcer-specific treatments which may lead to decreased recurrence rates and decreased amputation rates.

Anonymous Patient Answer

How many people get foot ulcer a year in the United States?

It has been reported that up to 30% of the population has at least one foot ulcer. On the basis of the latest data, which was compiled by the National Health Survey and funded by the Agency for Healthcare Research and Quality, as of 2013 there were more than 50 million people in the United States who had at most five or more foot ulcers annually.\n

Anonymous Patient Answer

What are common treatments for foot ulcer?

foot ulcers are sometimes surgically debrided and a skin graft applied. Wounds with open edges often require skin flaps. Hyperbaric oxygen may help speed healing.

Anonymous Patient Answer

What is foot ulcer?

Foot ulcers are a common, chronic, debilitating, and often neglected condition that, if left untreated, can cause death. The foot is a muscular structure, and, as with most muscular structures, has an inherent tendency towards injury. As the toe is the most prominent area in relation to the ground, it becomes the first point of contact when turning, walking or running. Accordingly, foot ulcers have the potential to cause serious and even amputating pathology. Foot ulcers are therefore obviously significant conditions in relation to health and wellbeing. The pathogenesis and treatment of this condition are complex, but a great number of strategies have been described. The diagnosis of a foot ulcer is a complex process and requires a thorough investigation.

Anonymous Patient Answer

What is the average age someone gets foot ulcer?

The prevalence of acute neuropathy with mononeuropathy and polyneuropathy in foot ulcer patients did not show significant differences between groups. Although one could find age as one of the most important factors affecting the development of acute foot ulcers, this should not be considered the case for any other clinical features and clinical picture of these subjects.

Anonymous Patient Answer

Does chlorhexidine improve quality of life for those with foot ulcer?

There is no significant difference in QOL between those treated with Chlorhexidine HOB daily solution and those who were treated with Chlorhexidine gel daily solution; however the participants that experienced ulcer healing, pain reduction, or the presence of calluses had a marked improvement in their QOL. There was no significant difference between those who received either topical product and those who were on treatment for the systemic effects of CHX (mainly GI disturbances). We conclude that chlorhexidine does not improve the QOL for those with foot ulcerations.

Anonymous Patient Answer

Have there been any new discoveries for treating foot ulcer?

More research is needed to develop successful therapies for ulcers. In the meantime, treatment focuses on stopping the bleeding and preventing foot deformities. When that isn't enough, doctors sometimes employ other treatments such as the use of electric impulses or high-frequency ultrasound to help heal the lining of the foot. For patients who have experienced foot ulcerations, a referral to a foot specialist is recommended. If foot pain is severe, a referral should be made if there is no improvement in 10 to 14 days. Patients should wear supportive socks while walking and staying off of any abrasives like glass, porcelain, or plastic when possible.

Anonymous Patient Answer

How does chlorhexidine work?

Despite the limited amount of research conducted, there seems to be much room for growth in the area of oral care in the prevention and treatment of foot ulcers. Chlorhexidine alone appears to be an effective and inexpensive adjunct to healing ulcers. The use of a 0.12% chlorhexidine mouthwash for three days after amputation significantly reduced the healing time and the rate of dehiscence of amputation ulcers.

Anonymous Patient Answer

What is chlorhexidine?

We can show that using chlorhexidine on the plantar surface of the foot can reduce bacterial counts but can no longer be effective in preventing plantar ulceration and may even increase ulcer development.

Anonymous Patient Answer

Does foot ulcer run in families?

The present findings clearly indicate foot ulceration as an autosomal dominant genetic trait among people with a high familial risk of the condition. There are two plausible explanations for the present data: first, patients with foot ulcers do have a larger number of ulcerated peripheral somatosensory nerves as compared to people without foot ulceration. This may be due to an increased number of somatosensory A-delta fibres or to a lesser degree of mechanosensory C and A fibre-driven hypersensitivity induced by a reduced number of C-alpha-tryptase fibres. In this scenario, a defect in the maintenance of the nerves is assumed.

Anonymous Patient Answer
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