Far-IR Emitted by Compression Stockings for Cellulitis Treatment

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

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.

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Cellulitis
• Intervention / Treatment: Other: No far-IR compression stockings; Other: Far-IR compression stockings

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Stockings side one; This side of the compression stockings is just the fabric (placebo).	Other: 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: Stocking side two; This side of compression stocking emits far-IR radiation.	Other: 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.

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Investigators: Principal Investigator: Edileia Bagatin, M.D., PhD, Universidade Federal de Sao Paulo, Brasil

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): November 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: August 28, 2011
• First Submitted That Met QC Criteria: September 4, 2011
• First Posted (Estimate): September 7, 2011

Study Record Updates

• Last Update Posted (Estimate): September 7, 2011
• Last Update Submitted That Met QC Criteria: September 4, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Treatment; Cellulitis; Skin ultra-sound images; Infra-red light
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Inflammation; Connective Tissue Diseases; Skin Diseases, Infectious; Suppuration; Cellulitis
• Other Study ID Numbers: SIGVARIS; SigvarisUnifesp (Other Grant/Funding Number: Sigvaris do Brasil)