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

Primary Purpose

Diabetes Mellitus

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
sunflower oil
Ozone Therapy
Sponsored by
Philozon Geradores de Ozonio LTDA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Ozone, Sunflower oil, diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Associação Hospitalar Beneficente São Vicente de PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ozone therapy

sunflower oil

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
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.

Secondary Outcome Measures

Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.
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.

Full Information

First Posted
June 29, 2012
Last Updated
July 16, 2012
Sponsor
Philozon Geradores de Ozonio LTDA
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1. Study Identification

Unique Protocol Identification Number
NCT01643967
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot
Acronym
PHIOZO0110
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philozon Geradores de Ozonio LTDA

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
Ozone, Sunflower oil, diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ozone therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
sunflower oil
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
sunflower oil
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ozone Therapy
Other Intervention Name(s)
Philozon, MedPlus, Ozone Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the efficacy and safety of ozone released by the device Philozon Medplus in the treatment of patients with diabetic foot.
Description
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.
Time Frame
65 days
Secondary Outcome Measure Information:
Title
Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.
Description
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.
Time Frame
65 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renato T Santos, Investigator
Phone
5554-3312-2099
Email
renatotadeus@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Keyla L Deucher, Coordinator
Phone
5554-2103-4064
Email
pesquisaclinica.hsvp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz L Pfluck, Investigator
Organizational Affiliation
Pronto Socorro de Fraturas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marcelo C Burihan, Investigator
Organizational Affiliation
Hospital Santa Marcelina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renato t Santos, Investigator
Organizational Affiliation
Associação Hospitalar Beneficente São Vicente de Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associação Hospitalar Beneficente São Vicente de Paulo
City
Passo Fundo
State/Province
Rio Grande do Sul
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato T Santos, Investigator
Phone
5554-3312-2099
Email
renatotadeus@gmail.com
First Name & Middle Initial & Last Name & Degree
Keyla L Deucher, Coordinator
Phone
5554- 3316-4000
Email
pesquisaclinica.hsvp@gmail.com
First Name & Middle Initial & Last Name & Degree
Renato T Santos, Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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