CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
Chlorhexidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03503370
NCT03503370Phase 2Completed

Preventing Diabetic Foot Ulcers Through Manipulating the Skin Microbiota

VA Office of Research and Development·interventional·Posted Apr 19, 2018·Updated Aug 9, 2024

In Brief

A Phase 2 clinical trial evaluating Chlorhexidine and Placebo for Diabetic Foot Ulcer. Completed, enrolled 175 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 19, 2018
Enrollment StartJan 2, 2019
Primary CompletionDec 30, 2022
Study CompletionJan 6, 2023
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 8.2 years ago

Interventions

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.