NCT01096589已完成不适用
Preliminary Study to Assess the Effectiveness of 3M Oedema Reduction System in the Treatment of Lymphoedema Treatment Compared to Comprilan Short-stretch Bandage Compression Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 11
- 主要终点
- Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
研究概览
简要总结
Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging.
Secondary objectives:
- Assessment of safety
- Quality of life
- Health economic parameters
- Slippage
- Subbandage pressure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Mobile males or females, age 18 years or older
- •Unilateral arm lymphoedema of secondary origin
- •Pitting arm lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
- •Patients who require intense bandaging therapy (approx. >= 15% increase in arm volume over the opposite healthy arm)
- •Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation
- •Willing to give written informed consent and willing to comply with the study protocol
- •Inclusion Criteria (Leg):
- •Mobile males or females, age 18 years or older
- •Unilateral or bilateral leg lymphoedema of primary or secondary origin
- •Pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
- •Patients who require intense bandaging therapy
- •Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation
- •Willing to give written informed consent and willing to comply with the study protocol
排除标准
- •Known pregnancy
- •Evidence of active cancer, either local or metastatic
- •A period of intense daily bandaging within the last month
- •Decompensated heart failure or clinically relevant kidney or liver disease
- •Known relevant arterial disease of the arms
- •Deep vein thrombosis or phlebitis in the last 3 months
- •Paralysis of the arms
- •Clinical infection of the arms (e.g. erysipelas)
- •Wounds located at the study arm that require dressing change more than once a week
- •History of allergic reactions to study material
- •Participation in any prospective clinical study that can potentially interfere with this study
- •Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
- •Exclusion Criteria (Leg):
- •Known pregnancy
- •Evidence of active cancer, either local or metastatic
- •A period of intense daily bandaging within the last month
- •Decompensated heart failure or clinically relevant kidney or liver disease
- •Deep vein thrombosis or phlebitis in the last 3 months
- •Known relevant arterial disease of the legs
- •Paralysis of the legs
- •Clinical infection of the legs (e.g. erysipelas)
- •Circumferential Lymphorrhoea
- •Wounds located at the study leg that require dressing change more than once a week
- •History of allergic reactions to study material
- •Participation in any prospective clinical study that can potentially interfere with this study
- •Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
研究组 & 干预措施
Arm 1 - 3M Coban 2
Experimental
3M Coban 2 - 2 apps/wk
干预措施: 3M Coban 2 (Compression System) (Device)
Arm 2 - 3M Coban 2
Experimental
3M Coban 2 - 3 apps/wk
干预措施: 3M Coban 2 (Compression System) (Device)
Arm 3 - 3M Coban 2
Experimental
Arm 3 - 3M Coban 2 - 5 apps/wk
干预措施: 3M Coban 2 (Compression System) (Device)
Arm 4 - Comprilan
Active Comparator
Comprilan short-stretch bandage 5 apps/wk
干预措施: Comprilan (Device)
结局指标
主要结局
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
时间窗: baseline and after 3 weeks of treatment
次要结局
- Assessment of Safety by Incidence of Adverse Events.(3 weeks)
研究者
研究点 (11)
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