Basic Toolbox for Lipedema Syndrome Assessment ("BATOLISA")
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To observe the fluorescence in the extracellular matrix surrounding the superficial lymphatic vessels.
研究概览
简要总结
Until today lipedema diagnosis is based on the evaluation of a body of non-specific clinical signs. Studies so far have centered around the weakness of collagen. Lipoedema patients have a tortuous superficial venous network probably due to the fragility of collagen type 3 involved in the architecture of the different vessels. Superficial lymphatic vessels are normally porous but in lipedema patients this porosity seems to be augmented. The main objective of the study is to compare the porosity of the superficial lymphatic vessels of women with lipedema vs healthy subjects so as to determine the adequacy of ICG lymph-fluoroscopy as a diagnostic tool.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for LIPEDEMA PATIENTS:
- •Age: 18-50 y.o. (non-menopausal)
- •Signed informed consent form
- •Waist to hip ration </= 0.7
- •Easy bruising
- •Pain level (VAS) >/=4
- •Lipedema syndrome diagnosed by a health professional
- •Inclusion criteria HEALTHY SUBJECTS - 1-4 AS ABOVE (
- •age: 18-50 (non menopausal);
- •BMI: 18-300;
- •Signed informed consent form
排除标准
- •Allergy to iodine or shellfish
- •Oncologic history
- •Hyperthyroïdisme
- •Autonomus thyroid adenoma
- •Hypersensitivity to Indocyanine green
- •Skin lesions
- •Male subjects
- •Menopause or perimenopause period
- •Breastfeeding
- •Refusal and/or incapacity to give informed consent form
- •Advanced renal impairment
- •Known coagulation disorders
- •Use of anticoagulants
结局指标
主要结局
1. To observe the fluorescence in the extracellular matrix surrounding the superficial lymphatic vessels.
1. To observe the fluorescence in the extracellular matrix surrounding the superficial lymphatic vessels.
次要结局
- To quantify the mean velocity of the bolus displacement between two reference points placed over the collectors 50mm apart.
- 2. To measure the occlusion pressure of the superficial lymphatic collectors (below 160mmHg).
研究者
Jean-Paul Belgrado
Scientific
Universite Libre de Bruxelles