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
2 other identifiers
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 28, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 7, 2011
September 1, 2011
4 months
August 28, 2011
September 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Changes in Cellulitis clinical grade
0, 30, 60 and 90 days
Subject evaluation
day 90th
Changes in Anthropometric measures
0, 30, 60 and 90 days
Changes in Photographies
0, 30, 60 and 90 days
Changes in Skin viscoelasticity
0, 30, 60 and 90 days
- +4 more secondary outcomes
Study Arms (2)
Stockings side one
PLACEBO COMPARATORThis side of the compression stockings is just the fabric (placebo).
Stocking side two
ACTIVE COMPARATORThis side of compression stocking emits far-IR radiation.
Interventions
The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Vascular disease
- Psychiatric disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edileia Bagatin, M.D., PhD
Universidade Federal de Sao Paulo, Brasil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., PhD - Professor
Study Record Dates
First Submitted
August 28, 2011
First Posted
September 7, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2011
Study Completion
March 1, 2012
Last Updated
September 7, 2011
Record last verified: 2011-09