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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Stockings side one
This side of the compression stockings is just the fabric (placebo).
|
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.
|
|
활성 비교기: Stocking side two
This side of compression stocking emits far-IR radiation.
|
The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in ultra-sound images
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Cellulitis clinical grade
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Edileia Bagatin, M.D., PhD, Universidade Federal de Sao Paulo, Brasil
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SIGVARIS
- SigvarisUnifesp (기타 보조금/기금 번호: Sigvaris do Brasil)
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