A randomized clinical trial to compare early versus delayed endovenous treatment of superficial venous reflux in patients with chronic venous ulceration

Imperial College London (UK)0 sites450 target enrollmentOctober 3, 2013

Overview

Registry

who.int

Start Date

October 3, 2013

End Date

June 30, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

Imperial College London (UK)

•1\. Current leg ulceration of greater than 6 weeks, but less than 6 months duration
•2\. Able to give informed consent to participate in the study after reading the patient information documentation
•3\. Patient age \> 18 years
•4\. Ankle Brachial Pressure Index (ABPI) greater than or equal to 0\.8
•5\. Superficial venous disease on colour duplex assessment deemed to be significant enough to warrant ablation by
•the treating clinician (either primary or recurrent venous reflux)
•Patients who cannot speak/understand English will be eligible for inclusion and informed consent will be obtained with assistance from translation services as per standard clinical practice. In view of the lack of cross cultural validation for quality of life tools, only healing outcome data will be collected.

•1\. Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention
•2\. Patients who are unable to tolerate any multilayer compression bandaging will be excluded. However, concordance with compression therapy can be variable for patients at different times. Patients who are generally compliant with compression but unable to tolerate the bandages for short periods will still be eligible for inclusion. A period of noncompliance with compression bandages will not be considered a protocol violation, but a normal variation within the spectrum of standard therapy.
•3\. Inability of the patient to receive prompt endovenous intervention by the recruiting centre
•4\. Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
•5\. Leg ulcer of nonvenous aetiology (as assessed by the responsible clinician)
•6\. If patient is deemed to require skin grafting they cannot be included