Chronic Venous Hypertension With Ulcer and Inflammation Clinical Trial
Official title:
Long-term Healing and Recurrence of Chronic Venous Ulcerations Following Ultrasound-guided Foam Sclerotherapy
The purpose of this study is to determine long term healing rates of chronic venous ulcers (CVU) after ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR) and to relate recurrence of CVU to evidence of recanalisation and the presence of superficial or deep venous reflux
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.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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Phase 0 | |
| Completed |
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N/A |