Prospective Multicentre Study to Evaluate the Clinical Performance and Safety of Innovative, Made-to-measure Compression Garments in Daily Routine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 8
- 主要终点
- Clinical performance: circumference of the edema
研究概览
简要总结
The primary objective is to collect real-life data to evaluate the clinical performance and safety of innovative, made-to-measure, flat knitted, CE-marked compression garments for daytime treatment of leg or arm lymphedema (ISL stage I-II) in daily routine by analysing performance parameters and safety parameters reported during the investigation.
详细描述
The secondary objective is to evaluate (1) patients' quality of life QoL before and after having tested JOBST Confidence and (2) patient satisfaction focussing on patient reported outcomes of previously worn garments and JOBST® Confidence by analysing patient questionnaires parameters completed at the beginning and in the end of the wearing period.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form
- •Men, women or diverse aged 18 years or up to 70 years with full legal competence
- •Patient is mentally and physically able to participate in the study
- •Capability to understand the subject information and to provide conscious informed consent
- •Capability and willingness to follow protocol requirements
- •All female or diverse subjects of childbearing potential must agree to use a reliable method of contraception with a Pearl-Index of less than 1% per year when used consistently and correctly* (*such as hormone implants,injectables, combined oral contraceptives (combined gestagen-estrogen pills), some intra uterine devices (IUDs), surgically sterility (hysterectomy or tubal ligation), sexual abstinence or vasectomized partner for at least 4 weeks)
- •Mild to moderate lymphedema of the lower and/or upper extremities (ISL stage I or II)
- •Indication and possibility of treatment with a flat-knitted compression garment during the day
- •Patients who are familiar with wearing compression garments
- •Indicated Complete Decongestive Therapy Phase II (Maintenance phase)
- •Willingness to wear the study product at least 5 days a week for at least 6 hours a day
排除标准
- •Pregnant or lactating women or diverse subjects
- •Alcohol abuse (mentioned by the patient and/or suspected by the investigator)
- •Drug abuse (mentioned by the patient and/or suspected by the investigator)
- •Patients who need a different compression class (higher or lower than CCL 2)
- •Pronounced skin folds
- •Pronounced shape distortions
- •cG (lymphatic measure of the thigh) >90 cm for AG stocking
- •Indicated Complete Decongestive Therapy Phase I
- •Known allergy or intolerance to one or more components of the product
- •Advanced arterial insufficiency including ischemia
- •Uncontrolled congestive heart failure
- •Untreated septic phlebitis
- •Phlegmasia coerulea dolens
- •Immobility (confinement to bed).
- •Conditions in which increased venous and lymphatic return is not desired.
- •Weeping dermatosis
- •Cutaneous infections
- •Severely compromised skin sensibility and impaired sensitivity of the limb
- •Advanced peripheral neuropathy
- •Rheumatoid arthritis
- •Complex regional pain syndrome (CRPS, M. Sudeck)
- •Malignant lymphedema
- •Sponsors or manufacturers staff
- •Open wounds in the test area
- •Diuretics, except low doses for treatment of hypertension (≤ 12.5 mg Hydrochlorothiazide)
- •Nephrotic syndrome
结局指标
主要结局
Clinical performance: circumference of the edema
时间窗: change from baseline after a treatment duration of 7, 14, and 21 days
Circumference measurements at selected points of the limb (taken manually using measuring tape) \[cm\]
Clinical performance: edema status
时间窗: change from baseline after a treatment duration of 7, 14, and 21 days
Evaluation of edema (visual inspection and palpitation) according to standardized criteria
次要结局
- Patient satisfaction assessed by patient questionnaire(assessed before treatment and after 21 days of treatments with JC)
- Quality of Life assessed by patient questionnaire(assessed before treatment and after 21 days of treatments with JC)