Far-IR Emitted by Compression Stockings for Cellulitis Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Edileia Bagatin, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01429428
First received: August 28, 2011
Last updated: September 4, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Cellulitis
Quality of Life
Other: Far-IR compression stockings
Other: No far-IR compression stockings

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

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Changes in ultra-sound images [ Time Frame: 0, 30, 60 and 90 days ] [ Designated as safety issue: No ]
    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:
  • Changes in Cellulitis clinical grade [ Time Frame: 0, 30, 60 and 90 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: day 90th ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0, 30, 60 and 90 days ] [ Designated as safety issue: No ]
    The circumference of thighs, hip and waist are measured in standardized points

  • Changes in Photographies [ Time Frame: 0, 30, 60 and 90 days ] [ Designated as safety issue: No ]
    By using the OMNIA device standardized photos are taken in three positions: front buttocks and side view of thighs

  • Changes in Skin viscoelasticity [ Time Frame: 0, 30, 60 and 90 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 0 and 90 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30, 60 and 90 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30, 60 and 90 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0 and 90 days ] [ Designated as safety issue: Yes ]
    Superficial and deep venous systems will be evaluate before and at the end of the study by colour eco-doppler


Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429428

Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Edileia Bagatin, M.D., PhD Universidade Federal de Sao Paulo, Brasil
  More Information

No publications provided

Responsible Party: Edileia Bagatin, M.D., PhD - Professor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01429428     History of Changes
Other Study ID Numbers: SIGVARIS, SigvarisUnifesp
Study First Received: August 28, 2011
Last Updated: September 4, 2011
Health Authority: Brasil: Brazilian Regulatory Agency (Agência Nacional de Vigilânca Sanitária, ANVISA, Portuguese)

Keywords provided by Federal University of São Paulo:
Cellulitis
Skin ultra-sound images
Treatment
Infra-red light

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014