Far-IR Emitted by Compression Stockings for Cellulitis Treatment
NCT ID: NCT01429428
Last Updated: 2011-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2011-07-31
2012-03-31
Brief Summary
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The investigators expect that the far-IR effects on superficial microcirculation,deep dermis and subcutaneous fat may attenuate the clinical aspect of cellulitis.
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Detailed Description
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It is a multifactorial condition, involving: herniation of subcutaneous fat into deep dermis; vertical fibrous septum from fatty tissue to dermis; alterations in microcirculation; hormonal and inflammatory factors Clinical evaluation is very difficult and the best methods are: high resolution ultrasound and magnetic resonance.
There is no effective management. Many devices have been introduced to treat that aesthetic condition which causes a great discomfort to women. There are few controlled studies with high level methodology and consistent conclusions.
The far-IR radiation can be obtained by low energy emitting devices and its main effects are the interaction with water and temperature increase. This method had already shown efficacy for circulation system disorders and wound healing by activation of TGF-beta and fibroblasts.
Our aim is to evaluate the benefits of far-IR for cellulitis control.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Stockings side one
This side of the compression stockings is just the fabric (placebo).
No far-IR compression stockings
This side of compression stocking without far-IR radiation will be used by subjects, during the day, for six hours a day, during 90 days.
Stocking side two
This side of compression stocking emits far-IR radiation.
Far-IR compression stockings
The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.
Interventions
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Far-IR compression stockings
The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.
No far-IR compression stockings
This side of compression stocking without far-IR radiation will be used by subjects, during the day, for six hours a day, during 90 days.
Eligibility Criteria
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Inclusion Criteria
* Healthy women
* Age: 25 to 40 years
* Presence of cellulitis - II or III
* No treatment for cellulitis in the last 6 months
Exclusion Criteria
* Vascular disease
* Psychiatric disorder
25 Years
40 Years
FEMALE
Yes
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Edileia Bagatin
M.D., PhD - Professor
Principal Investigators
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Edileia Bagatin, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal de Sao Paulo, Brasil
Other Identifiers
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SigvarisUnifesp
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SIGVARIS
Identifier Type: -
Identifier Source: org_study_id
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