Far-IR Emitted by Compression Stockings for Cellulitis Treatment

Not Applicable

• Conditions: Cellulitis; Quality of Life
• Interventions: Other: No far-IR compression stockings; Other: Far-IR compression stockings

• Registration Number: NCT01429428
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-28
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-04
• Last Update Submitted: 2011-09-04
• Study First Posted: 2011-09-07
• Last Update Posted: 2011-09-07
• Primary Completion: 2011-11
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stockings side one	No far-IR compression stockings	This side of the compression stockings is just the fabric (placebo).
Stocking side two	Far-IR compression stockings	This side of compression stocking emits far-IR radiation.

Primary Outcome Measures

Name	Time	Method
Changes in ultra-sound images	0, 30, 60 and 90 days	High resolution ultra-sound (DemaScan, Cortex Technology, Denmark)is used to measure dermis density and thickness and distance between dermis and fatty tissue in the most evident two areas with cellulitis(thighs and buttocks)

Secondary Outcome Measures

Name	Time	Method
Changes in Cellulitis clinical grade	0, 30, 60 and 90 days	Main investigator evaluates the clinical aspect of cellulitis, i.e., the level of irregularity of skin surface, according to Nuremberg and Müller classification in four grades: 0: no alterations I: alterations only visible by pinching the skin or contracting the muscles II: skin orange or padded aspect is visible when the woman stands up or by pinching the skin or contracting the muscles III: the same alterations of II associated to skin elevations and nodulations
Subject evaluation	day 90th	Study subjects will give their opinion about modification on cellulitis appearance using a 5-point scale: much worse; worse; no change; better; much better
Changes in Anthropometric measures	0, 30, 60 and 90 days	The circumference of thighs, hip and waist are measured in standardized points
Changes in Photographies	0, 30, 60 and 90 days	By using the OMNIA device standardized photos are taken in three positions: front buttocks and side view of thighs
Changes in Skin viscoelasticity	0, 30, 60 and 90 days	Skin elasticity is measured by suction with the Cutometer device(Courage\&Khazaka, Germany) in the most evident two areas with cellulitis(thighs and buttocks)
Changes in DLQI scores	0 and 90 days	The application of the quality of life generic questionnaire named Dermatology Life Quality Index or DLQI(Finlay, 1994), version DLQI-Brasil (Ferraz, 2006) will be used to evaluate the impact of cellulitis and its treatment on women´s life
Occurence of adverse events	30, 60 and 90 days	Report and/or observation of side effects,such as discomfort, difficulty to use the stockings or any distress will be registered
Occurence of venous insufficiency signs	30, 60 and 90 days	Symptoms and signals of venous insufficiency such as fatigue, swelling, burning will be evaluate by a five-point scale:0=none; 1 = slight; 2 = slight to moderate; 3 = moderate to severe; 4 = severe; 5 = unbearable
Changes in Colour eco-doppler	0 and 90 days	Superficial and deep venous systems will be evaluate before and at the end of the study by colour eco-doppler