Longterm Outcomes of Venous Ulcers After Foam Sclerotherapy
Long-term Healing and Recurrence of Chronic Venous Ulcerations Following Ultrasound-guided Foam Sclerotherapy
研究概览
地位
条件
详细说明
This study is attempting to follow up the original cohort of patients who took part in the short- and mid-term study which may mean reduced patient numbers due to some inevitable patient deaths. Kaplan-Meier analysis will control for this. In terms of patient numbers, effort will be made to recruit as many patients as possible as this will increase the validity of the results. This could be a problem not only related to deaths of some of the patients but also the timeframe for completion of the project or a refusal of the patient to take part. Many of the patients are elderly and may not want to accept the invitation to come to the hospital. However, good follow-up rates were achieved in the mid-term study (around 80%) and familiarity with the team should aid recruitment as the same patients will be contacted.
In order to maintain validity and reliability of the study as part of a follow on, the methodology adopted for this project will be similar to that of the short-term study in terms of the way in which the information is gathered and the classification of the results. This will mean that if a comparison between the two is to be made, similar information is available and scientifically comparable. There should not be any significant intra and/or inter observer/operator variability with the results (different users technical ability with ultrasound) as collaboration between those responsible for collection of all the data and performing all diagnostic tests will be done to avoid any potential problems with validity. For this reason, assessments will be performed by the principal investigator under the guidance and supervision of the main research nurse responsible for data collection on the previous project. Results of this study will be analysed, evaluated and disseminated as a continuation of the previous short/mid-term study.
A possible limitation may be that patient recollection of their experience of any ulcer recurrences may be unreliable. This is an unavoidable problem but effort will be made to get the most accurate account as possible from the participants.
There is a possibility for bias of the long-term follow up results as it is more likely that patients who are having problems with their treatment results will accept the offer of additional follow-up rather than those patients who are fine. However, as all patients will be asked if they would like to participate via telephone if unwilling to come to the hospital for assessment, this should not affect research question 1.
研究类型
注册 (实际的)
联系人和位置
学习地点
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West Midlands
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Birmingham、West Midlands、英国、B9 5SS
- Heart of England NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
All patients who are unwilling or unable to consent will be excluded from the project. Any patients who have died since the mid-term study will not be contacted. All patients who are willing to attend will be entered into both outcome arms of the study analysis (see endpoints at the end of this section) and those who are unable to attend for an appointment but wish to take part will be posted a consent form and then entered into endpoint analysis 1.
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Exclusion Criteria:
N/A
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学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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ultrasound-guided foam sclerotherapy
This project is ongoing from an original study conducted by our research group looking at short- and mid-term clinical outcomes after UGFS.
The original patient cohort from the aforementioned study was made up of 132 patients who underwent UGFS between 1 March 2005 and 31 December 2009 for treatment of a chronic venous ulcer (CEAP classification C5 or C6 disease) with significant (>0.5s)
SVR confirmed with duplex ultrasound.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Ulcer-free survival following UGFS for the treatment of CVU
大体时间:Up to 5 months
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Up to 5 months
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次要结果测量
结果测量 |
大体时间 |
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Superficial/deep venus reflux-free survival following UGFS for CVU
大体时间:up to 5 months
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up to 5 months
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合作者和调查者
调查人员
- 首席研究员:Katy Bloom, MRes、Heart of England NHS Trust
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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