Far-IR Emitted by Compression Stockings for Cellulitis Treatment

Study Overview
=================
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.

Official Title
-----------------
Randomized and Controlled Study About Efficacy and Safety of Far-Infra Red Radiation Emitted by Compression Stockings for Cellulitis Treatment

Conditions
-----------------
Cellulitis, Quality of Life

Intervention / Treatment
-----------------
* Other: Far-IR compression stockings
* Other: No far-IR compression stockings


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Stockings side one<br>This side of the compression stockings is just the fabric (placebo). | Other: No far-IR compression stockings<br>* 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.<br>|
| Active Comparator: Stocking side two<br>This side of compression stocking emits far-IR radiation. | Other: Far-IR compression stockings<br>* The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ultra-sound images | 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) | 0, 30, 60 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Cellulitis clinical grade | 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 | 0, 30, 60 and 90 days | 
| Subject evaluation | Study subjects will give their opinion about modification on cellulitis appearance using a 5-point scale: much worse; worse; no change; better; much better | day 90th | 
| Changes in Anthropometric measures | The circumference of thighs, hip and waist are measured in standardized points | 0, 30, 60 and 90 days | 
| Changes in Photographies | By using the OMNIA device standardized photos are taken in three positions: front buttocks and side view of thighs | 0, 30, 60 and 90 days | 
| Changes in Skin viscoelasticity | Skin elasticity is measured by suction with the Cutometer device(Courage&Khazaka, Germany) in the most evident two areas with cellulitis(thighs and buttocks) | 0, 30, 60 and 90 days | 
| Changes in DLQI scores | 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 | 0 and 90 days | 
| Occurence of adverse events | Report and/or observation of side effects,such as discomfort, difficulty to use the stockings or any distress will be registered | 30, 60 and 90 days | 
| Occurence of venous insufficiency signs | 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 | 30, 60 and 90 days | 
| Changes in Colour eco-doppler | Superficial and deep venous systems will be evaluate before and at the end of the study by colour eco-doppler | 0 and 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cellulitis, Skin ultra-sound images, Treatment, Infra-red light