DRKS00031131已完成不适用
Evaluation of pain (Numeric Rating Scale (NRS) under flat knitted medical compression of the lower extremities in patients with lipedema (explorative study)
eurocom e.V. (european manufacturers federation for compression therapy and orthopaedic devices)0 个研究点目标入组 24 人开始时间: 2023年1月20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
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Female
入选标准
- •written informed consent
- •- female of at least 18 years of age
- •- confirmed diagnosis of lipedema
- •- no contraindication against flat-knitted compression garnment
- •- expected good compliance in regards to wearing compression stockings ( at least 6 hours per day on at least 6 days a week) and study-related activties (study visits, completion of ePRO)
- •- actual pain in the leg of at least 4.0 on the NRS at V0
- •daily access to smartphne, tablet or PC for using ePRO
排除标准
- •- pregnant or breast feeding women
- •- women of childbearing potential who intend to become pregnant during study conduct
- •- isolated lipedema in the lower leg without participation of upper leg
- •-diagnosis lymphedema, plebedema or myxedema
- •- use of flat-knitted compression therapy for the management of the lipedema in the 4 weeks before study inclusion as well as in the time between inclusion and handover of test product
- •-actual or planned therapy of the lipedema (including psychotherapy, manual lymph drainage, physio therapy etc)
- •- planned liposuction within the next 3-6 months
- •- already occured liposuction
- •- patients who have requested disability pension benefit or plan to do so
- •-any pain causing comorbidities, which will interfere with the pain symptomatic of the lipedema
- •- advanced arterial occlusive disease defined as ABPI < 0,5, pressure in arteria of the ankle < 60 mmHg, toe pressure < 30 mmHg oder TcPO2 < 20 mmHg footback
- •-decompensated heart insufficiency (NYHA III+IV)
- •- septic superficial vein thrombosis (phlebitis)
- •-phlegmasia coerula dolens
- •- presence of one or several of following risks: intensive weeping dermatosis, intolerability to the compression material, severe sensibility disturbance of the extremity, advanced peripheral neuropathy (e.g. in diabetes mellitus), primary chronic polyarthritis
- •- comorbidities which in the judgement of the investigator influences or interferes with the assessment of the study endpoint
- •- alcohol- or drug abuse
- •-regular pain treatment (e.g. medication)
- •-particpation in another clinical study (actual or within the last 4 weeks)
- •-study participation who are dependent on sponsor, manufacturer, CRO or site
研究者
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