Axial Ablation Versus Terminal Interruption of the Reflux Source

Venous Ulcer Clinical Trial

— AAVTIRS  

Official title:

Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484168
• Other study ID #: CA2416
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: October 2022

Study information

• Verified date: May 2022
• Source: University College Hospital Galway
• Contact: Colum R Keohane, MB,BCh,BAO
• Phone: 00353876492372
• Email: columkeohane[@]rcsi.ie
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Varicose Ulcer
• Venous Ulcer

Intervention

Procedure:
• Terminal Interruption of the Reflux Source
Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
• Axial Ablation
Endovenous ablation of venous reflux in the main superficial veins of the leg

Locations

Country	Name	City	State
Ireland	Roscommon Unversity Hospiral	Roscommon

Sponsors (6)

Lead Sponsor	Collaborator
University College Hospital Galway	Marie O'Shaughnessy, Mark Twyford, Stewart R Walsh, Thomas A Aherne, Wael Tawfick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer healing	The main outcome measure is the proportion of ulcers which have healed within the follow up period	6 months
Secondary	Ulcer Healing	The proportion of ulcers healed at three months	3 months
Secondary	Reduction in ulcer size	The absolute reduction in ulcer size in square cm	6 months
Secondary	Relative Reduction in ulcer size	Reduction in ulcer size as a percentage of original ulcer area	6 months
Secondary	Wound Progress	Progress in Wound regeneration as indicated by changes in Bates-Jensen Wound Assessment Tool (BWAT)	6 months
Secondary	Change in overall venous disease	Monthly change in Venous Clinical Severity Score	6 months
Secondary	Change in Venous disease related quality of Live	Changes in Charing Cross Venous Ulcer Quesionnaire score from randomisation to exit from the study	6 months