Diabetes MellitusPhase 3PHIOZO0110NCT01643967
Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot
A Phase 3 study testing sunflower oil and Ozone Therapy in people with Diabetes Mellitus, run by Philozon Geradores de Ozonio LTDA at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- sunflower oil and Ozone Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Associação Hospitalar Beneficente São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Renato T Santos, Investigator, 5554-3312-2099, renatotadeus@gmail.com
Keyla L Deucher, Coordinator, 5554- 3316-4000, pesquisaclinica.hsvp@gmail.com
About this study
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.
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.
Read the 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).
- Conditions
- Diabetes Mellitus
- Being tested
- sunflower oil, Ozone Therapy
- Keywords
- Ozone, Sunflower oil, diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunflower oilOther
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.
Ozone TherapyOther
Also called Philozon, MedPlus, 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.
| Study group | Role | What they receive |
|---|---|---|
| Ozone therapy | Experimental | 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. Receives: Other: sunflower oil |
| sunflower oil | Active comparator | 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 Receives: Other: Ozone Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 65 days
Secondary outcomes (1)
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.
Measured: 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philozon Geradores de Ozonio LTDA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luiz L Pfluck, Investigator, Principal investigator, Pronto Socorro de FraturasMarcelo C Burihan, Investigator, Principal investigator, Hospital Santa MarcelinaRenato t Santos, Investigator, Principal investigator, Associação Hospitalar Beneficente São Vicente de Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643967
- Sponsor's protocol ID
- PHI-OZO-01-10
- Acronym
- PHIOZO0110
- Status last verified
- Jul 2012
- First submitted
- 29 Jun 2012
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01643967
- Acronym / sponsor ID
- PHIOZO0110 / PHI-OZO-01-10
- Conditions
- Diabetes Mellitus
- Keywords
- Ozone, Sunflower oil, diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Philozon Geradores de Ozonio LTDAIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone therapy | Experimental | Other: sunflower oilThe 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. |
| sunflower oil | Active comparator | Other: Ozone TherapyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunflower oilThe 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 | Ozone therapy |
| Ozone TherapyAlso: Philozon, MedPlus, Ozone TherapyThe 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 |
Primary outcome
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.
1 secondary outcome
Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.
Time frame: 65 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz L Pfluck, Investigator principal investigator
Pronto Socorro de Fraturas
Marcelo C Burihan, Investigator principal investigator
Hospital Santa Marcelina
Renato t Santos, Investigator principal investigator
Associação Hospitalar Beneficente São Vicente de Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sunflower oil and Ozone Therapy in people with Diabetes Mellitus, run by Philozon Geradores de Ozonio LTDA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renato T Santos, Investigator (5554-3312-2099, renatotadeus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.