跳至主要内容
临床试验/NCT05364112
NCT05364112招募中不适用

Utilization of Compreflex Wraps in Patients With Chronic Venous Insufficiency: A Quasiexperimental Post-market Clinical Follow-up Study

Kuala Lumpur General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Wound size

研究概览

简要总结

This is a multicentre, quasi-experimental study to evaluate the Conformitè Europëenne-marked Compreflex standard calf and foot (with basic liner) under routine conditions.

The study will be conducted at 4 clinics and will include 100 consecutive patients. Patients will be followed-up until 26 weeks.

详细描述

In chronic venous insufficiency (CVI), the venous system of the legs is ineffective in performing venous return, and there is venous reflux due to valve failure, physical inactivity and cardiovascular problems, leading to an increase in the pressure in the veins and venous hypertension. Chronic venous insufficiency includes a range of signs and symptoms, including varicose veins, varicose veins, oedema, skin lesions and ulcers.

Venous ulcers are wounds that occur due to improper functioning of venous valves secondary to severe chronic venous insufficiency. They are mainly located in the internal lateral zone of the distal third of the leg. Ulcers of venous aetiology make up 80% of all ulcers. They have an incidence of between 15 to 30 per 100'000 personyears.

The median healing time for chronic venous ulcers approximates 180 days. These ulcers may produce a foul-smelling discharge, can become infected and cause pain, which, in combination with slow healing and frequent relapses, affects the quality of life of affected patients.

The treatment of chronic venous ulcers requires a comprehensive approach for the patient, addressing the etiological factors that determine their evolution, such as venous insufficiency, diet, physical inactivity and postural measures. Local treatment has two components: local ulcer healing and control of venous insufficiency by means of compression therapy.

There is evidence that compression therapy promotes the healing process of venous ulcers. However, there is a large number of compression garments available and it is unclear which method of compression is the most effective. Traditionally, multilayered compression banding was the first line management for uncomplicated venous ulcers. This serves to increase venous return and reduce venous hypertension, as well as reduce oedema and improve lymphatic circulation. Despite its importance and widespread use, it has been reported that ca. 50% of patients do not comply with their multilevel bandaging. Reasons for non-compliance are skin irritation, bandage slippage, pain, malodor, inability to maintain hygiene, and discomfort and inability to wear normal footwear. Over recent years, there has been development of several Velcro-based wrap devices for use as alternative compression bandaging for venous ulcer management, using either interlacing or overlapping technique of wrapping. Systematic reviews have been undertaken for Velcro wrap devices, including their use in chronic edema, lipedema, and lymphedema, as well as venous ulceration. These systematic reviews were able to show a reduction in limb volume and more consistent sub-bandage pressure in Velcro wrap devices compared with bandaging. In addition, one of the major advantages that was reported was the relative ease to remove and reapply these devices, which can, therefore, encourage self-care, improve independence and, potentially, quality of life.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Are patients for whom it is medically indicated to use the device of interest in accordance with its instruction for use
  • •Are between 18 and 80 years old
  • •Have provided informed consent
  • •Are willing and able to participate in the follow-up examinations

排除标准

  • •Lymphoedema
  • •Presence of other comorbidities (i.e. congestive cardiac failure, renal failure, fulminant hepatic failure)
  • •Pregnancy
  • •Septicemia
  • •Infected chronic venous ulcer wound
  • •Ischemia (ABSI<0.8)
  • •Noncompressible arteries (ABSI<0.8)
  • •Bleeding tendencies

研究组 & 干预措施

Compreflex

Experimental

Patients recruited for the study will be given one unit of Compreflex (study device) to be worn on the studied leg with a venous ulcer. Once the wound is covered by dressing, the subjects were instructed to wear the study device for 24 hours over the study period. Subjects were allowed to take off the study device during a shower. Subjects were asked to visit the clinic for follow-up purposes at 3 assessment time points after being recruited at the first visit: V2 (3-week), V3 (12-week) and V4 (26-week). Subjects' wound area, leg circumferences were measured and calculated. Patient-centred questionnaires were given to the subjects to assess their compliance and satisfaction with the study device.

干预措施: Compreflex (Device)

结局指标

主要结局

Wound size

时间窗: 26 months

Ulcer size will be measured by Measuring the length "head-to-toe" at the longest point. Measure the width side-to-side at the widest point that is perpendicular to the length. The inner border of the wound will be used for reference, both for length and width.

次要结局

  • Oedema volume(26 months)

研究者

发起方
Kuala Lumpur General Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr Harikrishna K.Ragavan Nair

Head of Wound Care Unit, Department of Medicine

Kuala Lumpur General Hospital

研究点 (1)

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