Cellulitis, Quality of Life
Conditions
Keywords
Cellulitis, Skin ultra-sound images, Treatment, Infra-red light
Brief summary
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.
Detailed description
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.
Interventions
OTHERFar-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.
OTHERNo 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.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ultra-sound images | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject evaluation | 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 |
| Changes in Cellulitis clinical grade | 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 |
| Changes in Anthropometric measures | 0, 30, 60 and 90 days | The circumference of thighs, hip and waist are measured in standardized points |
| Changes in Photographies | 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 |
| Changes in Skin viscoelasticity | 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) |
| Changes in DLQI scores | 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 |
| Occurence of adverse events | 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 |
| Occurence of venous insufficiency signs | 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 |
| Changes in Colour eco-doppler | 0 and 90 days | Superficial and deep venous systems will be evaluate before and at the end of the study by colour eco-doppler |
Outcome results
None listed