Venous Ulcer
Conditions
Brief summary
This randomised trial aims to compare the effect on ulcer healing of different means of managing venous reflux in the lower limb. It is a non-inferiority trial comparing endovenous ablation of the axial (Saphenous and other large veins) veins of the lowere limb, versus terminal interruption of the reflux source (TIRS). For the purposes of this trial TIRS will be achieved using foam sclerotherapy of the distal tributaries in the immediate vicinity of the ulcer being treated.
Interventions
PROCEDURETerminal Interruption of the Reflux Source
Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
PROCEDUREAxial Ablation
Endovenous ablation of venous reflux in the main superficial veins of the leg
Sponsors
Stewart R Walsh
Wael Tawfick
Thomas A Aherne
Mark Twyford
Marie O'Shaughnessy
University College Hospital Galway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Primary or recurrent venous leg ulcer Long or short saphenous vein reflux confirmed on ultrasound assessment, defined as retrograde flow lasting for \>0.5 seconds Ankle-Brachial pressure Index (ABI) ≥ 0.8 (if ulceration prevents ABI Toe-Brachial Index(TBI) ≥ 0.5 acceptable), or a palpable pulse Ulcer size between 1 and 200 cm2 Patient suitable for full compression bandaging
Exclusion criteria
Pregnancy (or breastfeeding and needing to feed within 48 hours of treatment) Active infection of ulcer, or infection within the last two weeks Leg ulcer of non-venous aetiology as determined by clinical assessment Isolated perforator vein reflux only Evidence of deep venous insufficiency or thrombosis Known hypersensitivity to Sotradecol or similar sclerosants Previous inability to tolerate compression bandages Presence of any contraindications for the use of compression bandages: Absence of a palpable pulse, and Ankle Brachial Index (ABI) \<0.8 Decompensated congestive cardiac failure (NYHA Class IV) Known hypersensitivity to any of the component materials Patients unable to provide informed consent Patients attending the leg ulcer clinic already will be excluded from enrolment with the same ulcer but will be eligible to enrol with a contralateral ulcer. Recurrent ipsilateral ulcers will not be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer healing | 6 months | The main outcome measure is the proportion of ulcers which have healed within the follow up period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in ulcer size | 6 months | The absolute reduction in ulcer size in square cm |
| Relative Reduction in ulcer size | 6 months | Reduction in ulcer size as a percentage of original ulcer area |
| Ulcer Healing | 3 months | The proportion of ulcers healed at three months |
| Change in overall venous disease | 6 months | Monthly change in Venous Clinical Severity Score |
| Change in Venous disease related quality of Live | 6 months | Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study |
| Wound Progress | 6 months | Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT) |
Countries
Ireland
Contacts
Primary ContactColum R Keohane, MB,BCh,BAO
Backup ContactStewart R Walsh, MCh,MD
Outcome results
None listed