NCT05616962已完成不适用
Vasculera in Participants With Lipedema an Exploratory Controlled Case Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Weight From Baseline
研究概览
简要总结
This study is designed to gain preliminary information via a uniform protocol regarding the clinical effects of Vasculera in participants with lipedema and the possible role of the glycocalyx as a physiological target for Vasculera activity. It is anticipated that the results of this case study will inform the development of a formal randomized, double-blind, placebo controlled trial.
详细描述
The goal of this type of clinical trial is to compare the measurement of participants legs before treatment and after using the treatment for approximately 3 months in clinic patients 20 to 70 years old with lipedema. The main questions it aims to answer are: does the leg circumference decrease and does the participants' overall wellbeing improve?
Participants will:
- Have physical examinations and measurements at baseline and 3 month visit
- Complete wellbeing self-assessments at baseline and 3 month visit
- Have blood drawn for chemical markers at baseline and 3 month visit
- Complete four visits total
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •established diagnosis of lipedema for at least one (1) year
- •women, ages 20 to 70 years
- •score of at least 4 out of 10 on self-assessment on a 0-10 scale (10=worst) for overall sense of well being
- •be willing to stop compression therapy for one week prior to each visit
排除标准
- •other forms of leg enlargement, including lymphedema
- •any primary systemic vasculopathy
- •history of exposure to Vasculera or other diosmin containing medication within one (1) year of the screening visit
- •concomitant use of warfarin, platelet inhibitors, factor Xa inhibitors or any medication intended to reduce blood coagulability
- •concomitant use of diclofenac, metronidazole or chlorzoxazone
- •uncontrolled hypertension (BP>170/110), unstable cardiac disease, active skin ulceration
- •any other disease or condition that, in the opinion of the investigator, might put the
- •subject at risk by participation in this study OR confound evaluation of response to Vasculera
- •history of substance abuse within one (1) year of the screening visit or of current alcohol consumption more than one (1) unit daily. For purposes of this study, a unit of alcohol will be considered to be 12 oz of beer, 6 oz of wine or 1 oz of hard spirits.
结局指标
主要结局
Change in Weight From Baseline
时间窗: Visit 4 (3 months)
Weight in kilograms on digital, calibrated bathroom scale
次要结局
- Percentage Change Right Leg at 2 Inches(Visit 4 (3 month))
- Change in BMI From Baseline(Visit 4 (3 months))
- Change in Short Western Ontario and McMaster Universities Osteoarthritis Index Total Score From Baseline(Visit 4 (3 months))
- Change in Right Leg Discomfort From Baseline(Visit 4 (3 months))
- Change in Left Leg Discomfort From Baseline(Visit 4 (3 months))
- Change in Left Leg Feeling of Swelling or Tightness From Baseline(Visit 4 (3 months))
- Change in Right Leg Feeling of Swelling or Tightness From Baseline(Visit 4 (3 months))
- Change in Right Leg Tenderness From Baseline(Visit 4 (3 months))
- Change in Left Leg Tenderness From Baseline(Visit 4 (3 months))
- Change in Right Leg Bruising From Baseline(Visit 4 (3 months))
- Change in Left Leg Bruising From Baseline(Visit 4 (3 months))
- Change in Right Leg Redness(Visit 4 (3 months))
- Change in Left Leg Redness(Visit 4 (3 months))
- Change in Fatigue(Visit 4 (3 months))
- Change in Ability to Perform Activities of Daily Living(Visit 4 (3 months))
- Change in the Overall Sense of Wellbeing(Visit 4 (3 months))
- Investigator Assessment of Response to Therapy(Visit 4 (3 months))
- Percentage Change Right Leg at 12 Inches(Visit 4 (3 month))
- Percentage Change Left Leg at 2 Inches(Visit 4 (3 month))
- Percentage Change Left Leg at 12 Inches(Visit 4 (3 month))
研究者
研究点 (2)
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BATOLISAipoedema, LipedemaMedDRA version: 21.1Level: PTClassification code: 10063955Term: Lipoedema Class: 100000004861MedDRA version: 20.0Level: LLTClassification code: 10063956Term: Lipedema Class: 10027433CTIS2024-513529-21-00niversite Libre de Bruxelles60