Clinical trial NCT04484168: Axial Ablation Versus Terminal Interruption of the Reflux Source
Official title: Axial Ablation Versus Terminal Interruption of the Reflux Source (AAVTIRS): A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Ulcer
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
Collaborators: name: Stewart R Walsh
name: Wael Tawfick
name: Thomas A Aherne
name: Mark Twyford
name: Marie O'Shaughnessy
First posted: 2020-07-23
Enrollment: 308
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ulcer healing
timeFrame: 6 months
Secondary outcomes:
measure: Ulcer Healing
timeFrame: 3 months
measure: Reduction in ulcer size
timeFrame: 6 months
measure: Relative Reduction in ulcer size
timeFrame: 6 months
measure: Wound Progress
timeFrame: 6 months
measure: Change in overall venous disease
timeFrame: 6 months
measure: Change in Venous disease related quality of Live
timeFrame: 6 months
Other outcomes:
Locations:
city: Roscommon
country: Ireland
facility: Roscommon Unversity Hospiral
Study officials:
affiliation: UCH Galway and NUI Galway
name: Colum R Keohane, MB,BCh,BAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Keohane CR, Westby D, Twyford M, Ahern T, Tawfick W, Walsh SR. Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial. Trials. 2022 Jun 10;23(1):483. doi: 10.1186/s13063-022-06440-4.