Clinical trial NCT01429428: Far-IR Emitted by Compression Stockings for Cellulitis Treatment
Official title: Randomized and Controlled Study About Efficacy and Safety of Far-Infra Red Radiation Emitted by Compression Stockings for Cellulitis Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cellulitis
Quality of Life
Keywords: Cellulitis
Skin ultra-sound images
Treatment
Infra-red light
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in ultra-sound images
timeFrame: 0, 30, 60 and 90 days
Secondary outcomes:
measure: Changes in Cellulitis clinical grade
timeFrame: 0, 30, 60 and 90 days
measure: Subject evaluation
timeFrame: day 90th
measure: Changes in Anthropometric measures
timeFrame: 0, 30, 60 and 90 days
measure: Changes in Photographies
timeFrame: 0, 30, 60 and 90 days
measure: Changes in Skin viscoelasticity
timeFrame: 0, 30, 60 and 90 days
measure: Changes in DLQI scores
timeFrame: 0 and 90 days
measure: Occurence of adverse events
timeFrame: 30, 60 and 90 days
measure: Occurence of venous insufficiency signs
timeFrame: 30, 60 and 90 days
measure: Changes in Colour eco-doppler
timeFrame: 0 and 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Sao Paulo, Brasil
name: Edileia Bagatin, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: