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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Stockings side one
This side of the compression stockings is just the fabric (placebo).
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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.
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Comparador activo: Stocking side two
This side of compression stocking emits far-IR radiation.
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The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in ultra-sound images
Periodo de tiempo: 0, 30, 60 and 90 days
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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)
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0, 30, 60 and 90 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Changes in Cellulitis clinical grade
Periodo de tiempo: 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
|
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Subject evaluation
Periodo de tiempo: day 90th
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Study subjects will give their opinion about modification on cellulitis appearance using a 5-point scale: much worse; worse; no change; better; much better
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day 90th
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Changes in Anthropometric measures
Periodo de tiempo: 0, 30, 60 and 90 days
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The circumference of thighs, hip and waist are measured in standardized points
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0, 30, 60 and 90 days
|
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Changes in Photographies
Periodo de tiempo: 0, 30, 60 and 90 days
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By using the OMNIA device standardized photos are taken in three positions: front buttocks and side view of thighs
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0, 30, 60 and 90 days
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Changes in Skin viscoelasticity
Periodo de tiempo: 0, 30, 60 and 90 days
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Skin elasticity is measured by suction with the Cutometer device(Courage&Khazaka, Germany) in the most evident two areas with cellulitis(thighs and buttocks)
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0, 30, 60 and 90 days
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Changes in DLQI scores
Periodo de tiempo: 0 and 90 days
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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
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0 and 90 days
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Occurence of adverse events
Periodo de tiempo: 30, 60 and 90 days
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Report and/or observation of side effects,such as discomfort, difficulty to use the stockings or any distress will be registered
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30, 60 and 90 days
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Occurence of venous insufficiency signs
Periodo de tiempo: 30, 60 and 90 days
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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
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30, 60 and 90 days
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Changes in Colour eco-doppler
Periodo de tiempo: 0 and 90 days
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Superficial and deep venous systems will be evaluate before and at the end of the study by colour eco-doppler
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0 and 90 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Edileia Bagatin, M.D., PhD, Universidade Federal de Sao Paulo, Brasil
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SIGVARIS
- SigvarisUnifesp (Otro número de subvención/financiamiento: Sigvaris do Brasil)
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