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
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: Stockings side one
This side of the compression stockings is just the fabric (placebo).
|
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.
|
|
Comparatore attivo: Stocking side two
This side of compression stocking emits far-IR radiation.
|
The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in ultra-sound images
Lasso di tempo: 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)
|
0, 30, 60 and 90 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Changes in Cellulitis clinical grade
Lasso di tempo: 0, 30, 60 and 90 days
|
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
|
|
Subject evaluation
Lasso di tempo: day 90th
|
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
|
|
Changes in Anthropometric measures
Lasso di tempo: 0, 30, 60 and 90 days
|
The circumference of thighs, hip and waist are measured in standardized points
|
0, 30, 60 and 90 days
|
|
Changes in Photographies
Lasso di tempo: 0, 30, 60 and 90 days
|
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
|
|
Changes in Skin viscoelasticity
Lasso di tempo: 0, 30, 60 and 90 days
|
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
|
|
Changes in DLQI scores
Lasso di tempo: 0 and 90 days
|
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
|
|
Occurence of adverse events
Lasso di tempo: 30, 60 and 90 days
|
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
|
|
Occurence of venous insufficiency signs
Lasso di tempo: 30, 60 and 90 days
|
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
|
|
Changes in Colour eco-doppler
Lasso di tempo: 0 and 90 days
|
Superficial and deep venous systems will be evaluate before and at the end of the study by colour eco-doppler
|
0 and 90 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Edileia Bagatin, M.D., PhD, Universidade Federal de Sao Paulo, Brasil
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SIGVARIS
- SigvarisUnifesp (Altro numero di sovvenzione/finanziamento: Sigvaris do Brasil)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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