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| ID | Type | Description | Link |
|---|---|---|---|
| SigvarisUnifesp | Other Grant/Funding Number | Sigvaris do Brasil |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stockings side one | Placebo Comparator | This side of the compression stockings is just the fabric (placebo). |
|
| Stocking side two | Active Comparator | This side of compression stocking emits far-IR radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Far-IR compression stockings | Other | The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ultra-sound images | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cellulitis clinical grade | Main investigator evaluates the clinical aspect of cellulitis, i.e., the level of irregularity of skin surface, according to Nuremberg and MĂĽller 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edileia Bagatin, M.D., PhD | Universidade Federal de Sao Paulo, Brasil | Principal Investigator |
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| ID | Term |
|---|---|
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
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| No far-IR compression stockings | Other | 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. |
|
| 0, 30, 60 and 90 days |
| Subject evaluation | 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 | The circumference of thighs, hip and waist are measured in standardized points | 0, 30, 60 and 90 days |
| Changes in Photographies | 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 | 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 | 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 | 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 | 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 | Superficial and deep venous systems will be evaluate before and at the end of the study by colour eco-doppler | 0 and 90 days |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |