CellulitisNCT01429428
Far-IR Emitted by Compression Stockings for Cellulitis Treatment
A study testing Far-IR compression stockings and No far-IR compression stockings in people with Cellulitis and Quality of Life, run by Federal University of São Paulo.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cellulitis, Quality of Life
- What is being tested?
- Far-IR compression stockings and No far-IR compression stockings
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Vascular disease
- Psychiatric disorder
About this study
Official title: 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.
Read the 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.
- Conditions
- Cellulitis, Quality of Life
- Being tested
- Far-IR compression stockings, No far-IR compression stockings
- Keywords
- Cellulitis, Skin ultra-sound images, Treatment, Infra-red light
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far-IR compression stockingsOther
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 stockingsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stockings side one | Placebo comparator | This side of the compression stockings is just the fabric (placebo). Receives: Other: No far-IR compression stockings |
| Stocking side two | Active comparator | This side of compression stocking emits far-IR radiation. Receives: Other: Far-IR compression stockings |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0, 30, 60 and 90 days
Secondary outcomes (9)
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
Measured: 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
Measured: day 90th
Changes in Anthropometric measures
The circumference of thighs, hip and waist are measured in standardized points
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CellulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edileia Bagatin, Federal University of São Paulo
- Investigators
- Edileia Bagatin, M.D., PhD, Principal investigator, Universidade Federal de Sao Paulo, Brasil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429428
- Sponsor's protocol ID
- SIGVARIS
- Other IDs
- SigvarisUnifesp
- Status last verified
- Sep 2011
- First submitted
- 28 Aug 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Controlled Study About Efficacy and Safety of Far-Infra Red Radiation Emitted by Compression Stockings for Cellulitis Treatment
- ClinicalTrials.gov ID
- NCT01429428
- Acronym / sponsor ID
- SIGVARIS
- Conditions
- Cellulitis, Quality of Life
- Keywords
- Cellulitis, Skin ultra-sound images, Treatment, Infra-red light
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stockings side one | Placebo comparator | Other: No far-IR compression stockingsThis side of the compression stockings is just the fabric (placebo). |
| Stocking side two | Active comparator | Other: Far-IR compression stockingsThis side of compression stocking emits far-IR radiation. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Vascular disease
- Psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Far-IR compression stockingsThe far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days. | Other | Stocking side two |
| No far-IR compression stockingsThis side of compression stocking without far-IR radiation will be used by subjects, during the day, for six hours a day, during 90 days. | Other | Stockings side one |
Primary outcome
Changes in ultra-sound images
Time frame: 0, 30, 60 and 90 days
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)
9 secondary outcomes
Changes in Cellulitis clinical grade
Time frame: 0, 30, 60 and 90 days
Subject evaluation
Time frame: day 90th
Changes in Anthropometric measures
Time frame: 0, 30, 60 and 90 days
Changes in Photographies
Time frame: 0, 30, 60 and 90 days
Changes in Skin viscoelasticity
Time frame: 0, 30, 60 and 90 days
Changes in DLQI scores
Time frame: 0 and 90 days
Occurence of adverse events
Time frame: 30, 60 and 90 days
Occurence of venous insufficiency signs
Time frame: 30, 60 and 90 days
Changes in Colour eco-doppler
Time frame: 0 and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edileia Bagatin, M.D., PhD principal investigator
Universidade Federal de Sao Paulo, Brasil
Questions about this trial
What is this clinical trial studying?
A study testing Far-IR compression stockings and No far-IR compression stockings in people with Cellulitis and Quality of Life, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ultra-sound images (time frame: 0, 30, 60 and 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011; AzTrials last refreshed its copy on 6 Nov 2026.