Diabetic Foot UlcerPhase 2NCT03503370
Preventing Diabetic Foot Ulcers Through Cleaner Feet
A Phase 2 study testing Chlorhexidine in people with Diabetic Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Chlorhexidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2019to 6 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota
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.
Read the 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
- Being tested
- Chlorhexidine, Placebo
- Keywords
- topical chlorhexidine, prevention, clinical trial
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Experimental | 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. Receives: Drug: Chlorhexidine |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to New Foot Complication Among All Randomized Participants
Time in days to new foot complication (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to new foot complication; the results we are reporting are number of participants who developed a new foot complication in the 12 months post randomization). A new foot complication is defined as either 1) a new chronic (present 28 days from initial diagnosis) foot ulcer or wound or 2) a moderate or severe foot infection (as defined by IDSA Diabetic Foot Infection Severity classification: Table 2) not from an existing ulcer or 3) a foot amputation for a new ulcer.
Measured: 12 months
Secondary outcomes (1)
Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet
Susceptibility to chlorhexidine among bacterial pathogens on the feet. Chlorhexidine minimum inhibitory concentration (MIC) values were normalized across pathogens by subtracting the median MIC value (MIC50) from the literature for each pathogen from the observed MIC value on a log2() scale. The results we are reporting are the mean normalized MIC values and the Wilcoxon Rank Sum test comparing the difference in distribution of normalized MIC values. Effect size is expressed in means as this is more sensitive to group differences than the median. The possible range for the normalized observed MIC values on a log2() scale is from -8 to 8 with a higher value indicating that the pathogens collected were more resistant to chlorhexidine as compared to the median MIC values reported in the literature.
Measured: 4 weeks after stopping the intervention (approximately 13 months after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start2 Jan 2019
- Primary completion30 Dec 2022
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mary-Claire Roghmann, MD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503370
- Sponsor's protocol ID
- INFB-015-17F
- Status last verified
- Jun 2024
- First submitted
- 11 Apr 2018
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A limited dataset will be created and shared pursuant to a Data Use Agreement. Final data sets will be maintained locally until enterprise-level resources become available. Upon request, we will provide an electronic limited dataset to others in the scientific community with the implementation of appropriate data use agreements.
Publications
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.
PubMed 39964684
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota
- ClinicalTrials.gov ID
- NCT03503370
- Acronym / sponsor ID
- INFB-015-17F
- Conditions
- Diabetic Foot Ulcer
- Keywords
- topical chlorhexidine, prevention, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Drug: ChlorhexidineParticipants 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 | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineParticipants 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 |
| PlaceboParticipants 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 |
Primary outcome
Time to New Foot Complication Among All Randomized Participants
Time frame: 12 months
Time in days to new foot complication (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to new foot complication; the results we are reporting are number of participants who developed a new foot complication in the 12 months post randomization). A new foot complication is defined as either 1) a new chronic (present 28 days from initial diagnosis) foot ulcer or wound or 2) a moderate or severe foot infection (as defined by IDSA Diabetic Foot Infection Severity classification: Table 2) not from an existing ulcer or 3) a foot amputation for a new ulcer.
1 secondary outcome
Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet
Time frame: 4 weeks after stopping the intervention (approximately 13 months after randomization)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39964684Lydecker 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.
- Individual participant dataSharing planned: Yes. Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A limited dataset will be created and shared pursuant to a Data Use Agreement. Final data sets will be maintained locally until enterprise-level resources become available. Upon request, we will provide an electronic limited dataset to others in the scientific community with the implementation of appropriate data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary-Claire Roghmann, MD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chlorhexidine in people with Diabetic Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to New Foot Complication Among All Randomized Participants (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.