Far-IR Emitted by Compression Stockings for Cellulitis Treatment

Federal University of São Paulo

Status: Unknown

Conditions: Cellulitis; Quality of Life

Treatments: Other: Far-IR compression stockings; Other: No far-IR compression stockings

Study type: Interventional

Funder types: Other

Identifiers

NCT01429428

SigvarisUnifesp (Other Grant/Funding Number)

SIGVARIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Stockings side one

Placebo Comparator group

Description:

This side of the compression stockings is just the fabric (placebo).

Treatment:

Other: No far-IR compression stockings

Stocking side two

Active Comparator group

Description:

This side of compression stocking emits far-IR radiation.

Treatment:

Other: Far-IR compression stockings