Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot (PHIOZO0110)

July 16, 2012 updated by: Philozon Geradores de Ozonio LTDA

Clinical Trial, Open, Phase III, Multicenter, Randomized 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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Clinical trial, open, phase III, multicenter, prospective, comparative, controlled, randomized 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.
  • Primary Objective: evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
  • Secondary objective: evaluate ozone analyzer by environmental ozone Philozon Medplus released by the device in the clinical setting after using the device for rectal insufflation in a patient with diabetic foot.
  • Study population: Patients of both sexes, consisting of 100 patients over 18 years, patients with diabetic foot.
  • Treatment: 50 patients receive ozone therapy (topical and rectal insufflation of ozone). 50 patients will receive conventional treatment (Sunflower Oil).

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
        • Recruiting
        • Associação Hospitalar Beneficente São Vicente de Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Renato T Santos, Investigator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consent form signed;
  • Patients with Diabetes Mellitus Type I or Type II trophic lesions presenting in the lower limbs;
  • Injury whose largest diameter is less than 5 cm;
  • Patients of both sexes, aged above 18 years;
  • Heart rate 60 to 100 bpm.

Exclusion Criteria:

  • Presence of severe septic conditions;
  • IMC > 30;
  • Presence of Lymphedema;
  • Presence of trophic lesions in the lower limbs: exudative, traumatic and parasitic;
  • Trophic lesions caused by venous disease requiring treatment;
  • Hepatic or renal dysfunction;
  • History of alcohol abuse and drugs in the last 6 months;
  • Laboratory parameters:
  • hemoglobin < 10 g/dl;
  • Glycated hemoglobin > 9%;
  • Diagnosis of hyperthyroidism (TSH < 0.50 μUI/mL, free T4 > 1.80 ng/dL);
  • Deficit of Glucose 6 Phosphate Dehydrogenase (G6PD) > 20%;
  • Use of immunosuppressive drugs or anticonvulsants;
  • Pregnant woman or lactating;
  • Any significant medical condition which in the opinion of the Investigator may bring risks to the patient;
  • Known hypersensitivity to drugs and/or treatments to be used in the study;
  • Inability to compliance with the protocol;
  • Participation in another clinical trial for less than 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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 Names:

Sunflower oil
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.
Other Names:
  • Philozon, MedPlus, Ozone Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
Time Frame: 65 days
Evaluate the efficacy and safety of the release of ozone Medplus Philozon device in the treatment of patients with diabetic foot, through the clinical evaluation by the investigator based on the time needed for healing and decreasing the larger diameter of the lesion to be accompanied by image (photo), which register the size of the lesion in centimeters with a ruler.
65 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.
Time Frame: 65 days
Evaluate using ozone analyzer environmental ozone released by the device Philozon Medplus in the clinical setting after using the device for rectal insufflation in a patient with diabetic foot.
65 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philozon Geradores de Ozonio LTDA

Investigators

  • Principal Investigator: Luiz L Pfluck, Investigator, Pronto Socorro de Fraturas
  • Principal Investigator: Marcelo C Burihan, Investigator, Hospital Santa Marcelina
  • Principal Investigator: Renato t Santos, Investigator, Associação Hospitalar Beneficente São Vicente de Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

July 16, 2012

First Posted (Estimate)

July 18, 2012

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHI-OZO-01-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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