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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: 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.
|
|
Aktiver Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in ultra-sound images
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Changes in Cellulitis clinical grade
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Edileia Bagatin, M.D., PhD, Universidade Federal de Sao Paulo, Brasil
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SIGVARIS
- SigvarisUnifesp (Andere Zuschuss-/Finanzierungsnummer: Sigvaris do Brasil)
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