Back to resultsPreventing Diabetic Foot Ulcers Through Cleaner Feet
Primary Purpose
Diabetic Foot Ulcer
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Foot Ulcer focused on measuring topical chlorhexidine, prevention, clinical trial
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
chlorhexidine
placebo
Arm Description
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.
Participants randomized to the placebo will wash their feet using bath CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
Outcomes
Primary Outcome Measures
Foot complications
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 3) a foot amputation for a new ulcer.
Secondary Outcome Measures
Susceptibility to chlorhexidine and other antibiotics among bacterial pathogens
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.
Full Information
NCT ID
NCT03503370
First Posted
April 11, 2018
Last Updated
March 6, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03503370
Brief Title
Preventing Diabetic Foot Ulcers Through Cleaner Feet
Official Title
Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. This is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the recurrence of diabetic foot ulcers in Veterans with a recent history of a foot ulcer.
Detailed Description
Population: Up to 200 Veterans at risk for diabetic foot ulcer recurrence
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 recurrence 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
topical chlorhexidine, prevention, clinical trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chlorhexidine
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized to the placebo will wash their feet using bath CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Foot complications
Description
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 3) a foot amputation for a new ulcer.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Susceptibility to chlorhexidine and other antibiotics among bacterial pathogens
Description
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.
Time Frame
4 weeks after stopping the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary-Claire Roghmann, MD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Preventing Diabetic Foot Ulcers Through Cleaner Feet
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