This trial is active, not recruiting.

Conditions cellulitis, quality of life
Treatments far-ir compression stockings, no far-ir compression stockings
Sponsor Federal University of São Paulo
Start date July 2011
End date November 2011
Trial size 30 participants
Trial identifier NCT01429428, SIGVARIS, SigvarisUnifesp


This is a randomized and controlled study to investigate if the far-IR radiation emitted by compression stockings fabric may be effective and safe as adjuvant treatment for cellulitis that affects the majority of women after puberty.

The investigators expect that the far-IR effects on superficial microcirculation,deep dermis and subcutaneous fat may attenuate the clinical aspect of cellulitis.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Placebo Comparator)
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.
(Active Comparator)
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.

Primary Outcomes

Changes in ultra-sound images
time frame: 0, 30, 60 and 90 days

Secondary Outcomes

Changes in Cellulitis clinical grade
time frame: 0, 30, 60 and 90 days
Subject evaluation
time frame: day 90th
Changes in Anthropometric measures
time frame: 0, 30, 60 and 90 days
Changes in Photographies
time frame: 0, 30, 60 and 90 days
Changes in Skin viscoelasticity
time frame: 0, 30, 60 and 90 days
Changes in DLQI scores
time frame: 0 and 90 days
Occurence of adverse events
time frame: 30, 60 and 90 days
Occurence of venous insufficiency signs
time frame: 30, 60 and 90 days
Changes in Colour eco-doppler
time frame: 0 and 90 days

Eligibility Criteria

Female participants from 25 years up to 40 years old.

Inclusion Criteria: - Signed Consent Form - Healthy women - Age: 25 to 40 years - Presence of cellulitis - II or III - No treatment for cellulitis in the last 6 months Exclusion Criteria: - Pregnancy - Vascular disease - Psychiatric disorder

Additional Information

Official title Randomized and Controlled Study About Efficacy and Safety of Far-Infra Red Radiation Emitted by Compression Stockings for Cellulitis Treatment
Principal investigator Edileia Bagatin, M.D., PhD
Description Cellulitis is a sex-specific, anatomic and normal condition affecting women after puberty.The main clinical aspect is the irregularity on skin surface which is classified in 4 grades, 0 to III, according to Nurenberg classification, 1978. 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.