Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot (PHIOZO0110)
This study is currently recruiting participants.
Verified July 2012 by Philozon Geradores de Ozonio LTDA
Sponsor:
Philozon Geradores de Ozonio LTDA
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 May 16, 2013