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

June 29, 2012
July 16, 2012
June 2012
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01643967 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot
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.

  • 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).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • 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
  • 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
  • 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.
    Intervention: Other: 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

    Intervention: Other: Ozone Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Renato T Santos, Investigator 5554-3312-2099 renatotadeus@gmail.com
Contact: Keyla L Deucher, Coordinator 5554-2103-4064 pesquisaclinica.hsvp@gmail.com
Brazil
 
NCT01643967
PHI-OZO-01-10
Yes
Philozon Geradores de Ozonio LTDA
Philozon Geradores de Ozonio LTDA
Not Provided
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
Philozon Geradores de Ozonio LTDA
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP