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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to New Foot Complication Among Participants With a Healed Foot Complication at Randomization. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary-Claire Roghmann, MD | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39964684 | Derived | 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. |
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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.
The study protocol and statistical analysis plan are available now on the CT.gov page for this study. Final datasets underlying all publications will be made available upon publication of each paper.
Implementation of appropriate data use agreements. Email the study PI, Dr. Mary-Claire Roghmann (mroghmann@som.umaryland.edu), to start the process.
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Recruitment occurred between January 2019 and December 2021 in the Baltimore VA Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 months |
|
Adverse events were actively assessed from the enrollment visit until the final study visit for each participant. The time from enrollment visit to final study visit was typically 13 months for a given participant. Enrollment began in January 2019 and the final study visit occurred in December 2022.
Participants were asked about adverse events on a monthly basis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic foot infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary-Claire Roghmann | Baltimore VA Medical Center | (410) 706-0062 | Mary-Claire.Roghmann@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2023 | Dec 18, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 3, 2023 | Mar 6, 2023 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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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.
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| Placebo | 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. |
|
| 4 weeks after stopping the intervention (approximately 13 months after randomization) |
| 12 months |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Healed foot complication | Healed foot complication is defined as a chronic foot ulcer, a major foot infection or a partial foot amputation that has healed prior to the study randomization visit. The healed foot complication could be on either foot. | Count of Participants | Participants |
|
| OG001 | 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. 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. |
|
|
|
| Secondary | 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. | Participants must have at least one bacterial pathogen on their feet to be included. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks after stopping the intervention (approximately 13 months after randomization) |
|
|
|
|
| Other Pre-specified | Time to New Foot Complication Among Participants With a Healed Foot Complication at Randomization. | 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. | Participants must have had a healed foot complication at randomization to be included. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| 3 |
| 88 |
| 23 |
| 88 |
| 1 |
| 88 |
| EG001 | 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. 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. | 1 | 87 | 17 | 87 | 2 | 87 |
| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Brain aneurysm | Nervous system disorders | Systematic Assessment |
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| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Cervical radiculopathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest pain, NOS | Cardiac disorders | Systematic Assessment |
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| Concussion | Nervous system disorders | Systematic Assessment |
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| Congestive heart failure | Cardiac disorders | Systematic Assessment |
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| Dehydration | General disorders | Systematic Assessment |
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| Diabetic foot infection | Infections and infestations | Systematic Assessment |
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| External ear infection | Infections and infestations | Systematic Assessment |
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| Fall due to general weakness | General disorders | Systematic Assessment |
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| Gallstone pancreatitis | Gastrointestinal disorders | Systematic Assessment |
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| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hyperglycemia | Gastrointestinal disorders | Systematic Assessment |
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| Hyperkalemia | Renal and urinary disorders | Systematic Assessment |
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| Intracranial hemorrhage | Nervous system disorders | Systematic Assessment |
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| Kidney transplant | Renal and urinary disorders | Systematic Assessment |
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| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Muscle weakness, NOS | General disorders | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Near syncope, NOS | General disorders | Systematic Assessment |
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| Near syncope, NOS | Nervous system disorders | Systematic Assessment |
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| Opioid Use Disorder | Psychiatric disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Transient Ischemic Attack | Nervous system disorders | Systematic Assessment |
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| General disorders | Systematic Assessment |
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| Urinary track infection | Infections and infestations | Systematic Assessment |
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| Weakness, NOS | General disorders | Systematic Assessment |
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| Fall due to knee weakness | General disorders | Systematic Assessment |
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| Vaccine side effects | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |