A Prospective Randomized-controlled Trial of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
研究概览
简要总结
The purpose of this research study is to assess the efficacy of custom-manufactured compression hosiery (also known as compression stockings) compared to similar off-the-rack (OTR) compression stockings.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Ability to comprehend and sign an informed consent and complete study questionnaires
- •Patient is participating in usual work and home activities with no changes anticipated for the duration of the study
- •The use of compression stocking is prescribed in accordance with the usual practice and management of venous disorders
- •The patient will confirm they are willing to pay for the compression stockings.
排除标准
- •The patient has a known allergy to any component of the stocking (latex, etc)
- •The patient has non-venous source of pain in either leg that could, in the opinion of the investigator, confound the results of the study i.e.Neuropathy, Arterial insufficiency, Diabetes
- •The patient is confined to bed
- •The patient has uncontrolled Congestive Heart Failure
- •The patient has acute dermatitis
- •The patient has weeping dermatosis
- •Patients with venous ulcers will be excluded.
结局指标
主要结局
Mental/Emotional Functioning as Assessed by the SF-12 HRQoL Instrument Mental Component Summary (MCS)
时间窗: 6 months
The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life.
Pain Management Experienced During Their Postoperative Care as Assessed by Five-point Satisfaction Scale
时间窗: 6 months
Five-point satisfaction scale consists of patients rating their overall postoperative pain management experience using a 5-point rating system. The scale ranges from 1 to 5, with 1 being "extremely dissatisfied", 2 "somewhat dissatisfied", 3 "Neutral/Neither satisfied nor dissatisfied", 4 "somewhat satisfied" and 5 "extremely satisfied" with their postoperative pain care.
Pain as Assessed by Brief Pain Inventory
时间窗: 6 months
The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the World Health Organization Collaborating Center for Symptom Evaluation in Cancer Care. The score is an average of seven questions about pain interference in life. The score scale is from 0 to 10. 0 being pain does not interfere and 10 being that it completely interferes. 10 would be a worst outcome.
Overall Estimate of Functioning as Assessed by the SF-12 HRQoL Instrument (Overall HRQoL Estimate)
时间窗: 6 months
The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life.
Physical Functioning as Assessed by the SF-12 HRQoL Instrument Physical Component Summary (PCS)
时间窗: 6 months
The short-form 12 item (SF-12) HRQoL health status instrument measures Health-Related Quality of Life (HRQoL). It produces overall HRQoL estimates as well as sub-scale scores (Physical Component Summary (PCS) and Mental Component Summary (MCS)) that assess both mental/emotional and physical functioning related to health. The scoring scale is from 0 to 100, the higher the score the better the health related quality of life.
次要结局
- Number of Patients Who Will be Progressing to Ablation Therapy(6 months)
研究者
Stuart A Harlin
Associate Professor
The University of Texas Health Science Center, Houston