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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: 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.
|
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in ultra-sound images
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in Cellulitis clinical grade
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Edileia Bagatin, M.D., PhD, Universidade Federal de Sao Paulo, Brasil
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SIGVARIS
- SigvarisUnifesp (Ander subsidie-/financieringsnummer: Sigvaris do Brasil)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Kwaliteit van het leven
-
Rambam Health Care CampusOnbekendom LIF-niveau in navelstrengbloed van embryo's die IUGR zijn te vergelijken met degenen die AGA zijn