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Chlorhexidine Gluconate Solution at 0.125% vs Placebo for the Healing of Grade IIB Ulcers of Diabetic Foot

NCT03209466 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2019-03-15

No results posted yet for this study

Summary

There is controversy regarding the utility of antiseptics in wound management for diabetic foot ulcer syndrome. The aim of this study is to assess chlorhexidine gluconate at 0.125% vs. saline solution to reduce the ulcerated area in patients with diabetic ulcer syndrome. A clinical trial model to evaluate modifications in size and area is proposed. Patients to be included will be those with diabetic foot ulcers Graded II accordingly to the University of Texas wound classification system.

Conditions

  • Diabetic Foot

Interventions

DRUG

Chlorhexidine gluconate at 0.125%

Application every 24 hours, six weeks Intervention: Procedure: chlorhexidine gluconate

DRUG

Placebo Comparator with physiological saline sterile solution

Standard management and physiological saline sterile solution with application every 24 hours, six weeks Intervention.

Sponsors & Collaborators

  • Universidad de Guanajuato

    lead OTHER

Principal Investigators

  • Alejandro E Macias, MD · Universidad de Guanajuato

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2020-12-15
Completion
2020-12-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209466 on ClinicalTrials.gov