Chronic Venous Hypertension With Ulcer and InflammationNCT01990170
Longterm Outcomes of Venous Ulcers After Foam Sclerotherapy
An observational study of Chronic Venous Hypertension With Ulcer and Inflammation, run by Heart of England NHS Trust at 1 site in United Kingdom.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Hypertension With Ulcer and Inflammation
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Heart of England NHS Foundation Trust who took part in a previous study investigating Chronic Venous Ulcers.
Who may be able to join
- 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.
- -
Who cannot join
- N/A
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS
About this study
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
Read the detailed description
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.
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer-free survival following UGFS for the treatment of CVU
Measured: Up to 5 months
Secondary outcomes (1)
Superficial/deep venus reflux-free survival following UGFS for CVU
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Hypertension With Ulcer and InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart of England NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katy Bloom, MRes, Principal investigator, Heart of England NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990170
- Sponsor's protocol ID
- 2013080VS
- Status last verified
- Aug 2015
- First submitted
- 30 Oct 2013
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Healing and Recurrence of Chronic Venous Ulcerations Following Ultrasound-guided Foam Sclerotherapy
- ClinicalTrials.gov ID
- NCT01990170
- Acronym / sponsor ID
- 2013080VS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Heart of England NHS TrustUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Heart of England NHS Foundation Trust who took part in a previous study investigating Chronic Venous Ulcers.
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- N/A
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ulcer-free survival following UGFS for the treatment of CVU
Time frame: Up to 5 months
1 secondary outcome
Superficial/deep venus reflux-free survival following UGFS for CVU
Time frame: up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katy Bloom, MRes principal investigator
Heart of England NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Hypertension With Ulcer and Inflammation, run by Heart of England NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer-free survival following UGFS for the treatment of CVU (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.