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

NCT03209466 | Unknown Phase 4

• 1 other identifier: CHXDF
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chlorhexidine gluconate; Diabetic foot ulcer syndrome; Wound healing

Outcome Measures

Primary Outcomes (1)

• Ulcerated area

  area of diabetic foot ulcer measured with photographic register using a visual control of dimensions and a dedicated software for measurements.

  Up to 6 weeks

Study Arms (2)

Standard management and Chlorhexidine gluconate at 0.125%

EXPERIMENTAL

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

Drug: Chlorhexidine gluconate at 0.125%

Standard management and physiological saline sterile solution

PLACEBO COMPARATOR

Application every 24 hours, six weeks Intervention: Other: physiological saline sterile solution

Drug: Placebo Comparator with physiological saline sterile solution

Interventions

Chlorhexidine gluconate at 0.125% DRUG

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

Standard management and Chlorhexidine gluconate at 0.125%

Placebo Comparator with physiological saline sterile solution DRUG

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

Standard management and physiological saline sterile solution

Eligibility Criteria

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

You may qualify if:

• Ambulatory patients of both sex over age of 18 years old with diabetes mellitus that present an ulcer caused by diabetic foot syndrome with an extension from skin to tendon or join capsule and infected, classified as Texas IIB.

You may not qualify if:

• Patients lost to follow up and those that voluntary leave the study.

Sponsors & Collaborators

• Universidad de Guanajuato: lead

Study Sites (1)

Universidad de Guanajuato

León, Guanajuato, 37320, Mexico

RECRUITING

Related Publications (3)

• Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons. Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66. doi: 10.1016/S1067-2516(07)60001-5.

  PMID: 17280936 BACKGROUND

• Boulton AJ, Vileikyte L, Ragnarson-Tennvall G, Apelqvist J. The global burden of diabetic foot disease. Lancet. 2005 Nov 12;366(9498):1719-24. doi: 10.1016/S0140-6736(05)67698-2.

  PMID: 16291066 RESULT

• Stewart PS, Costerton JW. Antibiotic resistance of bacteria in biofilms. Lancet. 2001 Jul 14;358(9276):135-8. doi: 10.1016/s0140-6736(01)05321-1.

  PMID: 11463434 RESULT

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Alejandro E Macias, MD

  Universidad de Guanajuato

  STUDY DIRECTOR

Central Study Contacts

Jose A Alvarez, PhD

CONTACT

52 477 2674900; alvarez_ja@me.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 6, 2017
• Study Start: May 11, 2017
• Primary Completion: December 15, 2020
• Study Completion: December 30, 2020
• Last Updated: March 15, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)