NCT01558024已完成不适用
The Effects of Compression Stockings on Pressure Parameters in Patients With Chronic Venous Insufficiency
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2014年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 4
- 主要终点
- Correlation between D and A/F at the calf
研究概览
简要总结
The main objective of this study is to obtain data to determine, in each individual with and without wearing compression stockings of different strengths and during different postures, the relationship between interface pressure and the area and circumference of the great saphenous vein and posterior tibial veins in the calf and ankle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The participant must have given his/her informed and signed consent
- •The participant must be insured or beneficiary of a health insurance plan
- •Inclusion criteria for patients in the venous insufficiency group:
- •CEAP (Clinical-Etiology-Anatomy-Pathophysiology) Classification : C1S, C3 or C5
- •Inclusion criteria for healthy volunteers
- •general good health
- •subgroups including:
- •sedentary volunteers (< 2hours of physical activity per week)
- •active volunteers (between 2 and 6 hours of physical activity per week)
- •athletic volunteers (over 6 hours of physical activity per week for at least 1 year)
排除标准
- •The participant is participating in another study, except the "volumetric" counterpart to the present study
- •The participant is in an exclusion period determined by a previous study
- •The participant is under judicial protection, under tutorship or curatorship
- •The participant refuses to sign the consent
- •It is impossible to correctly inform the participant
- •The participant is pregnant, parturient, or breastfeeding
- •Arterial vascular disease, heart, lymph, renal, hepatic, oncologic, metabolic or endocrine or any other condition that may cause or exaggerate edema
- •Exclusion criteria for healthy volunteers:
- •Risk for abnormal bleeding (hemophilia, anticoagulation or antiplatelet)
- •Taking diuretics or corticoids
结局指标
主要结局
Correlation between D and A/F at the calf
时间窗: Baseline (Day 0)
D = the diameters of the largest cross section of the posterior tibial veins at calf level; A = the area of the largest cross section of the posterior tibial veins at the calf level; F = interface pressure measured along the leg using a 13 captor system.
次要结局
- Interface pressure for the leg(baseline; day 0)
- Venous pressure at the ankle (mmHg)(baseline; day 0)
- Heart height difference (mm); saphenous vein, ankle(baseline, day 0)
- Leg circumference (mm)(baseline; Day 0)
- Calf interstitial pressure(base line; day 0)
- Posterior tibial vein area, calf(baseline, day 0)
- Saphenous vein perimeter, calf(baseline, day 0)
- Posterior tibial vein perimeter, calf(baseline, day 0)
- Heart height difference (mm); posterior tibial vein, ankle(baseline, day 0)
- Saphenous vein area, ankle(baseline, day 0)
- Posterior tibial vein area, ankle(baseline, day 0)
- Saphenous vein perimeter, ankle(baseline, day 0)
- Saphenous vein area, calf(baseline, day 0)
- Heart height difference (mm); posterior tibial veins, calf(baseline, day 0)
- Posterior tibial vein perimeter, ankle(baseline, day 0)
- Heart height difference (mm); saphenous vein, calf(baseline, day 0)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
The Effect of Compression Stockings on the Complaints of Pregnant Women With Restless Leg SyndromeRestless Legs SyndromePregnancy RelatedSleep DisorderNCT05795868TC Erciyes University70
尚未招募
不适用
Pathophysiologic Study to Understand and Possibly Treat NocturiaNocturiaNCT05298384NYU Langone Health20
已完成
2 期
The Influence of Compression Stockings on Skin's Barrier Function at Patients With Chronic Venous DiseaseVenous InsufficiencyNCT00196443University Medicine Greifswald42
已完成
不适用
A study to evaluate the effect of compression garment and exercise on upper limb lymphedema in females with operated Breast Cancer.CTRI/2018/04/013055Dr ARUPRATAN GHOSH31
已完成
不适用
The effect of pneumatic compression stockings in haemodialysis patients: a randomised crossover trialEnd-stage kidney disease on haemodialysisUrological and Genital DiseasesChronic renal failureISRCTN74510183niversity of Calgary (Canada)51