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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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (実際)

25

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ile-de-France
      • Paris、Ile-de-France、フランス、75014
        • Groupe Hospitalier Paris Saint Joseph

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Assessment of change of pain numeric scale
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Assessment of change of distal arterial pressures of the compression carrier leg
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:STANSAL Audrey, MD、Groupe Hospitalier Paris Saint-Joseph (FRANCE)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2015年9月1日

一次修了 (実際)

2016年7月1日

研究の完了 (実際)

2016年7月1日

試験登録日

最初に提出

2016年7月13日

QC基準を満たした最初の提出物

2016年7月19日

最初の投稿 (見積もり)

2016年7月20日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年7月27日

QC基準を満たした最後の更新が送信されました

2016年7月26日

最終確認日

2016年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • ULCERE MIXTE

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未定

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