Preventing Diabetic Foot Ulcers Through Cleaner Feet

NCT03503370 | Completed Phase 2 Results

• 1 other identifier: INFB-015-17F
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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 occurrence of diabetic foot ulcers in Veterans at high risk of a diabetic foot ulcer.

Conditions

Diabetic Foot Ulcer

Keywords

topical chlorhexidine; prevention; clinical trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Susceptibility to Chlorhexidine Among Bacterial Pathogens on the Feet

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

Other Outcomes (1)

• Time to New Foot Complication Among Participants With a Healed Foot Complication at Randomization.

  12 months

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

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.

Chlorhexidine

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• 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.

  PMID: 39964684 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Mary-Claire Roghmann
• Organization: Baltimore VA Medical Center

Mary-Claire.Roghmann@va.gov

(410) 706-0062

Study Officials

• Mary-Claire Roghmann, MD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: January 2, 2019
• Primary Completion: December 30, 2022
• Study Completion: January 6, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 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.
• Access Criteria: Implementation of appropriate data use agreements. Email the study PI, Dr. Mary-Claire Roghmann (mroghmann@som.umaryland.edu), to start the process.

Locations

US (1)