Status:
UNKNOWN
Axial Ablation Versus Terminal Interruption of the Reflux Source
Lead Sponsor:
University College Hospital Galway
Collaborating Sponsors:
Stewart R Walsh
Wael Tawfick
Conditions:
Venous Ulcer
Eligibility:
All Genders
Phase:
NA
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 axi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT04484168
Start Date
July 21 2020
End Date
October 1 2022
Last Update
May 18 2022
Active Locations (1)
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1
Roscommon Unversity Hospiral
Roscommon, Ireland