Far-IR Emitted by Compression Stockings for Cellulitis Treatment

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01429428
• Other study ID #: SIGVARIS
• Secondary ID: SigvarisUnifesp
• Status: Active, not recruiting
• Phase: N/A
• First received: August 28, 2011
• Last updated: September 4, 2011
• Start date: July 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2011
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brasil: Brazilian Regulatory Agency (Agência Nacional de Vigilânca Sanitária, ANVISA, Portuguese)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cellulitis
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Changes in Anthropometric measures	The circumference of thighs, hip and waist are measured in standardized points	0, 30, 60 and 90 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes