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Effects of Compression in Mixed Ulcers (ULCEREMIXTE)

2016年7月26日 更新者:Groupe Hospitalier Paris Saint Joseph

About 15% to 30% of patients with venous leg ulcers have a peripheral arterial disease (PAD) associated. The compression band is still a controversial issue in this context. It allows the reduction of venous hypertension and edema, but it could potentially degrade the arterial infusion of high levels of compression. The French High Authority for Health (HAS) defines mixed ulcers by IPS between 0.5 and 0.9. Investigators distinguish mixed ulcers blood predominance for IPS between 0.5 and 0.7; and mixed ulcers predominantly venous blood with moderate involvement for IPS values between 0.7 and 0.9.

Several studies have shown that IPS> 0.8 allowed a high compression, between 30 and 40 mmHg. In the case of mixed ulcers with IPS between 0.6 and 0.8, the HAS recommends using a lighter compression, bit by elastic bands (exercising low power compression at rest) under medical supervision, informing the patient to remove the bandage if pain or aggravation. It is therefore necessary to adapt the compression therapy in case of venous ulcers associated with arterial disease by providing a lower compression 30 mmHg short stretch. For HAS, IPS <0.6 against indicates compression.

A recent study showed that compression bit elastic bands could not only improve venous return, but it would also increase the distal arterial flow in a patient population with mixed ulcers. In this study, 25 patients had between IPS 0.5 and 0.8; or for certain patients below the threshold of 0.6 indicates that against a compression according to HAS. To our knowledge this is the only study that has examined the effect of compression on blood perfusion.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Objectives:

  • Principal: Study the distal arterial infusion in a patient population with mixed ulcers under compression leg with little elastic bands
  • Secondary: To evaluate the safety of the little compression elastic band in a mixed population of patients with leg ulcers

Methodology :

  • Study non-interventional prospective single-center that evaluates professional practice from 25 patients with mixed leg ulcers and followed in the vascular medicine department of St. Joseph Hospital Group Paris.
  • Applying a bit compression elastic bandages to a pressure level between 30 and 40mmHg.
  • Anonymous data reports on the grid standardized collection, by a numbering system from 1 to 30 and then captured on a computer file

    • Age, risk factors and cardiovascular history of the patients,
    • Age, ulcer description
    • Palpation of pulse
    • morphological vascular profile of patients with arterial and venous Doppler dating less than a year,
    • Series following data before installation, 10 minutes after application and 24 hours after installation of the inelastic compression:

      o Evaluation of tolerance:

    • measurement of pain numeric scale (NS)
    • description of the skin condition of the leg by a dermatologist, seeking signs of suffering skin after application of compression: possible appearance of erythema, cyanosis, purpura. A search particularly in areas of bony prominences and the banks of the ulcer.

      o distal arterial pressures of the compression carrier leg:

    • IPS (systolic pressure index): ankle and arm pressures will be measured with a cuff and a continuous Doppler. GPI is calculated by dividing the lowest pressure at the ankle (at the dorsalis pedis or posterior tibial artery) by the humeral pressure.
    • Transcutaneous Oxygen Pressure (TcPO2) o Measuring pressure exerted by low elastic bandages by Kikuhime® system.

In case of bad tolerance of compression at any time after installation, the compression will be removed and the study stopped for the patient in question. Poor tolerance is defined by an increase in pain than or equal to 2 points on the digital scale.

expected benefits for patients:

  • Demonstration of good tolerance, defined as no worsening of the skin condition and the lack of increase in pain associated with inelastic compression.
  • Demonstration of no worsening of arterial infusion by inelastic compression.
  • Evidence of improved distal arterial hemodynamics (increased IPS and tcpO2) with a little elastic compression, which validate the results of the only study ever conducted on the subject.

研究类型

观察性的

注册 (实际的)

25

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ile-de-France
      • Paris、Ile-de-France、法国、75014
        • Groupe Hospitalier Paris Saint Joseph

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Subjects older than 18 years, suffering from an ulcer of mixed origin leg, and followed in the vascular medicine department of St. Joseph Hospital Group Paris.

描述

The mixed origin of the ulcer is defined by a venous disease (reflux in the superficial veins and / or deep) and a moderate arterial disease, defined by:

Inclusion Criteria:

  • A IPS 0.5 and 0.9, with a systolic pressure at the ankle> 70 mmHg
  • A big toe pressure index (IPGO) <0.7, with a systolic pressure of the big toe (PGO)> 50 mmHg

Exclusion Criteria:

  • Topics aged under 18,
  • A normal IPS that is to say between 0.9 and 1.3, a critical ischemia (defined as ankle pressure <70 mmHg and / or systolic pressure of the big toe <50 mmHg)
  • Presence of peripheral neuropathy,
  • Presence of heart failure,
  • Refusal to participate in the study or to sign the consent,
  • Impaired cognitive function not to participate in a clinical study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Assessment of change of pain numeric scale
大体时间:Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam

次要结果测量

结果测量
措施说明
大体时间
Assessment of change of distal arterial pressures of the compression carrier leg
大体时间:Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Assessment of change of IPS (systolic pressure index) ankle pressures
大体时间:Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Assessment of change of pressure exerted by low elastic bandage
大体时间:Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Measuring pressure exerted by low elastic bandages by Kikuhime® system.
Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Assessment of IPS (systolic pressure index) arm pressures
大体时间:Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam
Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:STANSAL Audrey, MD、Groupe Hospitalier Paris Saint-Joseph (FRANCE)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年9月1日

初级完成 (实际的)

2016年7月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2016年7月13日

首先提交符合 QC 标准的

2016年7月19日

首次发布 (估计)

2016年7月20日

研究记录更新

最后更新发布 (估计)

2016年7月27日

上次提交的符合 QC 标准的更新

2016年7月26日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • ULCERE MIXTE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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