Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot
PHIOZO0110
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.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus
Started Jun 2012
Shorter than P25 for phase_3 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJuly 18, 2012
July 1, 2012
6 months
June 29, 2012
July 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
65 days
Secondary Outcomes (1)
Evaluate the release of ozone in the environment by equipment MEdplus after insufflation rectal in patients with diabetic foot.
65 days
Study Arms (2)
Ozone therapy
EXPERIMENTALThe 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 COMPARATORThe 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Associação Hospitalar Beneficente São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 18, 2012
Study Start
June 1, 2012
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
July 18, 2012
Record last verified: 2012-07