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Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot

NCT01643967 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-07-18

No results posted yet for this study

Summary

This is a open, phase III, multicenter, prospective, comparative, controlled, randomized clinical trial to evaluate the efficacy and safety of the use of ozone released by Philozon Medplus device versus conventional therapy in treating patients with diabetic foot.

Conditions

Interventions

OTHER

sunflower oil

The research subjects allocated to this treatment arm will receive Sunflower Oil supplied by Philozon. Sunflower oil should be applied once daily for 60 days, it immediately after cleansing site where the lesion is present.

OTHER

Ozone Therapy

The research subject will receive topical and rectal insufflation of ozone three times a week on alternate days for two months or at least 12 sessions.

Sponsors & Collaborators

  • Philozon Geradores de Ozonio LTDA

    lead INDUSTRY

Principal Investigators

  • Luiz L Pfluck, Investigator · Pronto Socorro de Fraturas

  • Marcelo C Burihan, Investigator · Hospital Santa Marcelina

  • Renato t Santos, Investigator · Associação Hospitalar Beneficente São Vicente de Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT01643967 on ClinicalTrials.gov