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Far-IR Emitted by Compression Stockings for Cellulitis Treatment

4. september 2011 opdateret af: Edileia Bagatin, Federal University of São Paulo

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Stockings side one
This side of the compression stockings is just the fabric (placebo).
Andet: No far-IR compression stockings
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.
Aktiv komparator: Stocking side two
This side of compression stocking emits far-IR radiation.
Andet: Far-IR compression stockings
The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in ultra-sound images
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Cellulitis clinical grade
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federal University of São Paulo

Efterforskere

  • Ledende efterforsker: Edileia Bagatin, M.D., PhD, Universidade Federal de Sao Paulo, Brasil

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2011

Primær færdiggørelse (Forventet)

1. november 2011

Studieafslutning (Forventet)

1. marts 2012

Datoer for studieregistrering

Først indsendt

28. august 2011

Først indsendt, der opfyldte QC-kriterier

4. september 2011

Først opslået (Skøn)

7. september 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. september 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2011

Sidst verificeret

1. september 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SIGVARIS
  • SigvarisUnifesp (Andet bevillings-/finansieringsnummer: Sigvaris do Brasil)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Livskvalitet

Kliniske forsøg med No far-IR compression stockings

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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