A Study Evaluating the Efficacy of Cell-u-Light Apparel in Enhancing Lymph Drainage and Improving the Appearance of Grades of Cellulite in Affected Participants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- To calculate the volume of dimpling from the 3D scanner
研究概览
简要总结
This trial is arranged in 3 stages, lasting 8 weeks overall, designed to assess the before, during and after effects of the low-compression apparel with its integrated, variably raised, ink-polymer pads.
The study will recruit 21 (otherwise healthy) participants who are affected by cellulite. Volunteers will be selected in order to equally fill the 3 different grades of cellulite (7 volunteers of each grade (1, 2 & 3) - as Grade 0 is no evidence of cellulite, this category need not be included). Each volunteer will be 'sized' according to standard apparel sizing charts (as used by the manufacturer of the cycle shorts); Small (S), Medium (M), Large (L) and Extra Large (XL).
All participants will follow the same 3 stage sequence, which will involve a total of 9 short visits to The Whiteley Clinic, each lasting approximately 30 minutes. Upon completion of these visits, participants will each be offered £90 to subsidise their cost of travel - they will also be permitted to keep the low-compression apparel following the study. During each appointment, several measurements and assessment will be made:
- Standard demographics, weight, height, and any changes to dietary or exercise regimens over the trial period.
- Subjective assessment of the cellulite by the participant.
- Objective assessment and grading using the grading system described by Nunberger and Muller by the investigators
- Images of their cellulite-affected areas will be taken (this may include an area over the buttocks and an area over the thighs), using a high-resolution medical imaging (camera) system (Vectra H2 (https://www.canfieldsci.com/imaging-systems/vectra-h2-3d-imaging-system/)), to be independently assessed by Canfield Consultants and to be graded by a 'panel' of clinicians for objective classifications.
- Assessment of local lymphatic collections in the skin using a handheld lymph scanner to assess lymph accumulation (Delfin Lymphscanner, Delfin Technologies Ltd https://hadhealth.com/lymphscanner).
- During stage 2 only, participant assessment as to ease of donning and doffing the product, and comfort of wearing it.
详细描述
Stage 1:
The first stage of the trial is an induction and stabilisation phase. The participants will be seen on the first visit, the trail explained, and any questions answered. If the participant wishes to proceed, a consent form will be signed and the participant will be measured for the correct size Cell-u-Light product - but the product will NOT be given to the patient until visit 3, to prevent them from trying the product out before the trial stage.
They will then have the assessments performed and recorded. They will be given the time and dates of their next 8 weekly visits.
Visit 2 (end of week one) and visit 3 (end of week 3) will be part of stage 1. The Cell-u-light pants will not be given to the patient until visit 3 to
Stage 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Affected by stages 1, 2 or 3 of cellulite
- •Can be placed into one of the sizes of the apparel (S, M, L, or XL)
- •Have had no recent abdominal/leg surgery
- •Are physically able to apply and remove low-compression apparel safely
排除标准
- •Those on any special diets/medications that may affect weight especially hormone treatments that are changing such as IVF cycles
- •Any malignancy that is being actively investigated or treated
- •Any medical condition that is being actively investigated or treated
- •Anyone who is on special diets for weight loss or other health issues, with the exception of those on stable diets such a gluten free for coeliac.
- •Previous DVT
- •(Unusual/abnormal) leg swelling
- •Those who have had abdominal/leg operations within 1 year
- •Those who are not mobile
- •Those who are pregnant or planning to get pregnant
结局指标
主要结局
To calculate the volume of dimpling from the 3D scanner
时间窗: 9 weeks
Use this to objectively determine whether there is a change in appearance of cellulite with compression
次要结局
- Using a visual analogue score for the participants and two blinded observers to score the appearance of cellulite from 0 to 10, 0 being the worst, 10 being the best to statistically analyse whether the opinion of cellulite has changed(9 weeks)
研究者
Mark Whiteley
Consultant Venous Surgeon
The Whiteley Clinic