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
Verified date | August 2015 |
Source | Heart of England NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Observational |
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
Status | Completed |
Enrollment | 67 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Heart of England NHS Foundation Trust | Birmingham | West Midlands |
Lead Sponsor | Collaborator |
---|---|
Heart of England NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ulcer-free survival following UGFS for the treatment of CVU | Up to 5 months | No | |
Secondary | Superficial/deep venus reflux-free survival following UGFS for CVU | up to 5 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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