Longterm Outcomes of Venous Ulcers After Foam Sclerotherapy

NCT01990170 | Completed

• 1 other identifier: 2013080VS
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Venous Hypertension With Ulcer and Inflammation

Outcome Measures

Primary Outcomes (1)

• Ulcer-free survival following UGFS for the treatment of CVU

  Up to 5 months

Secondary Outcomes (1)

• Superficial/deep venus reflux-free survival following UGFS for CVU

  up to 5 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at Heart of England NHS Foundation Trust who took part in a previous study investigating Chronic Venous Ulcers.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Heart of England NHS Trust: lead

Study Sites (1)

Heart of England NHS Foundation Trust

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katy Bloom, MRes

  Heart of England NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 21, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 19, 2015

Record last verified: 2015-08

Locations

GB (1)