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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Philozon Geradores de Ozonio LTDA.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Philozon Geradores de Ozonio LTDA
ClinicalTrials.gov Identifier:
NCT01643967
First received: June 29, 2012
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Other: sunflower oil
Other: Ozone Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Philozon Geradores de Ozonio LTDA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 65 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Sunflower oil
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 Name: Philozon, MedPlus, Ozone Therapy

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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643967

Contacts
Contact: Renato T Santos, Investigator 5554-3312-2099 renatotadeus@gmail.com
Contact: Keyla L Deucher, Coordinator 5554-2103-4064 pesquisaclinica.hsvp@gmail.com

Locations
Brazil
Associação Hospitalar Beneficente São Vicente de Paulo Recruiting
Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
Contact: Renato T Santos, Investigator    5554-3312-2099    renatotadeus@gmail.com   
Contact: Keyla L Deucher, Coordinator    5554- 3316-4000    pesquisaclinica.hsvp@gmail.com   
Principal Investigator: Renato T Santos, Investigator         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Philozon Geradores de Ozonio LTDA
ClinicalTrials.gov Identifier: NCT01643967     History of Changes
Other Study ID Numbers: PHI-OZO-01-10
Study First Received: June 29, 2012
Last Updated: July 16, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Philozon Geradores de Ozonio LTDA:
Ozone
Sunflower oil
diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetic Neuropathies

ClinicalTrials.gov processed this record on September 22, 2014