Trial Outcomes & Findings for Preventing Diabetic Foot Ulcers Through Cleaner Feet (NCT NCT03503370)

NCT ID: NCT03503370

Last Updated: 2024-08-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 175 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2024-08-09

Participant Flow

Recruitment occurred between January 2019 and December 2021 in the Baltimore VA Medical Center.

Participant milestones

Measure	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.	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.
Overall Study STARTED	88	87
Overall Study COMPLETED	85	86
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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.	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.
Overall Study Death	3	1

Baseline Characteristics

Preventing Diabetic Foot Ulcers Through Cleaner Feet

Baseline characteristics by cohort

Measure	Chlorhexidine n=88 Participants 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.	Placebo n=87 Participants 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.	Total n=175 Participants Total of all reporting groups
Age, Continuous	67 years STANDARD_DEVIATION 8 • n=5 Participants	68 years STANDARD_DEVIATION 10 • n=7 Participants	68 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	85 Participants n=7 Participants	170 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	87 Participants n=5 Participants	87 Participants n=7 Participants	174 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	60 Participants n=5 Participants	57 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	88 Participants n=5 Participants	87 Participants n=7 Participants	175 Participants n=5 Participants
Healed foot complication	48 Participants n=5 Participants	43 Participants n=7 Participants	91 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Chlorhexidine n=88 Participants 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.	Placebo n=87 Participants 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.
Time to New Foot Complication Among All Randomized Participants	12 Participants	14 Participants

SECONDARY outcome

Timeframe: 4 weeks after stopping the intervention (approximately 13 months after randomization)

Population: Participants must have at least one bacterial pathogen on their feet to be included.

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.

Outcome measures

Measure	Chlorhexidine n=27 Participants 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.	Placebo n=28 Participants 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.
Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet	-1.83 units on a scale Standard Deviation 1.44	-1.88 units on a scale Standard Deviation 1.52

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: Participants must have had a healed foot complication at randomization to be included.

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.

Outcome measures

Measure	Chlorhexidine n=48 Participants 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.	Placebo n=43 Participants 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.
Time to New Foot Complication Among Participants With a Healed Foot Complication at Randomization.	11 Participants	12 Participants

Adverse Events

Chlorhexidine

Serious events: 23 serious events

Other events: 1 other events

Deaths: 3 deaths

Placebo

Serious events: 17 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Chlorhexidine n=88 participants at risk 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.	Placebo n=87 participants at risk 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anemia	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Cardiac disorders Bradycardia	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Nervous system disorders Brain aneurysm	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Infections and infestations COVID-19	3.4% 3/88 • 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.	1.1% 1/87 • 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.
Infections and infestations Cellulitis	2.3% 2/88 • 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.	1.1% 1/87 • 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.
Nervous system disorders Cerebrovascular accident	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Musculoskeletal and connective tissue disorders Cervical radiculopathy	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Cardiac disorders Chest pain, NOS	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Nervous system disorders Concussion	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Cardiac disorders Congestive heart failure	3.4% 3/88 • 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.	2.3% 2/87 • 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.
General disorders Dehydration	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Infections and infestations Diabetic foot infection	4.5% 4/88 • 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.	5.7% 5/87 • 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.
Infections and infestations External ear infection	1.1% 1/88 • 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.	0.00% 0/87 • 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.
General disorders Fall due to general weakness	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Gastrointestinal disorders Gallstone pancreatitis	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Musculoskeletal and connective tissue disorders Gout	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Gastrointestinal disorders Hyperglycemia	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Renal and urinary disorders Hyperkalemia	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Nervous system disorders Intracranial hemorrhage	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Renal and urinary disorders Kidney transplant	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer	0.00% 0/88 • 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.	1.1% 1/87 • 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.
General disorders Muscle weakness, NOS	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Cardiac disorders Myocardial infarction	1.1% 1/88 • 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.	1.1% 1/87 • 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.
General disorders Near syncope, NOS	0.00% 0/88 • 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.	1.1% 1/87 • 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.
Nervous system disorders Near syncope, NOS	1.1% 1/88 • 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.	1.1% 1/87 • 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.
Psychiatric disorders Opioid Use Disorder	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Infections and infestations Pneumonia	1.1% 1/88 • 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.	2.3% 2/87 • 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.
Nervous system disorders Transient Ischemic Attack	1.1% 1/88 • 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.	0.00% 0/87 • 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.
General disorders	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Infections and infestations Urinary track infection	2.3% 2/88 • 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.	1.1% 1/87 • 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.
General disorders Weakness, NOS	1.1% 1/88 • 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.	0.00% 0/87 • 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.

Other adverse events

Measure	Chlorhexidine n=88 participants at risk 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.	Placebo n=87 participants at risk 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.
Infections and infestations Diabetic foot infection	0.00% 0/88 • 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.	1.1% 1/87 • 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.
General disorders Fall due to knee weakness	1.1% 1/88 • 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.	0.00% 0/87 • 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.
Injury, poisoning and procedural complications Vaccine side effects	0.00% 0/88 • 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.	1.1% 1/87 • 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.

Additional Information

Dr. Mary-Claire Roghmann

Baltimore VA Medical Center

Phone: (410) 706-0062

Email: Mary-Claire.Roghmann@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place