Randomized and Controlled Study About Efficacy and Safety of Far-Infra Red Radiation Emitted by Compression Stockings for Cellulitis Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Changes in ultra-sound images
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnancy
- •Vascular disease
- •Psychiatric disorder
结局指标
主要结局
Changes in ultra-sound images
时间窗: 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)
次要结局
- Changes in Cellulitis clinical grade(0, 30, 60 and 90 days)
- Subject evaluation(day 90th)
- Changes in Anthropometric measures(0, 30, 60 and 90 days)
- Changes in Photographies(0, 30, 60 and 90 days)
- Changes in Skin viscoelasticity(0, 30, 60 and 90 days)
- Changes in DLQI scores(0 and 90 days)
- Occurence of adverse events(30, 60 and 90 days)
- Occurence of venous insufficiency signs(30, 60 and 90 days)
- Changes in Colour eco-doppler(0 and 90 days)
研究者
Edileia Bagatin
M.D., PhD - Professor
Federal University of São Paulo