Effects of Compression in Mixed Ulcers
关键词
抽象
描述
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.
日期
最后验证: | 06/30/2016 |
首次提交: | 07/12/2016 |
提交的预估入学人数: | 07/18/2016 |
首次发布: | 07/19/2016 |
上次提交的更新: | 07/25/2016 |
最近更新发布: | 07/26/2016 |
实际学习开始日期: | 08/31/2015 |
预计主要完成日期: | 06/30/2016 |
预计完成日期: | 06/30/2016 |
状况或疾病
干预/治疗
Other: No intervention
相
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
取样方式 | Non-Probability Sample |
接受健康志愿者 | 是 |
标准 | 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. |
结果
主要结果指标
1. Assessment of change of pain numeric scale [Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam]
次要成果指标
1. Assessment of change of distal arterial pressures of the compression carrier leg [Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam]
2. Assessment of change of IPS (systolic pressure index) ankle pressures [Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam]
3. Assessment of change of pressure exerted by low elastic bandage [Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam]
4. Assessment of IPS (systolic pressure index) arm pressures [Day 1, just before the exam, 10minutes after the exam and 24 hours after the exam]