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Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer

NCT ID: NCT03666754

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2023-12-31

Brief Summary

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The study evaluates the effects of early endovenous glue ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomized to receive early endovenous ablation (within 2 weeks) and a half to standard care

Detailed Description

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To get the venous leg ulcer to heal, the current best treatment is to wear a multi-component compression bandage, with which about 60% of these ulcers will heal within 24 weeks. There is evidence that treatment of the varicose veins by surgery will prevent the ulcer from returning after it has healed. Recent studies have suggested that newer techniques of treating varicose veins, such as sclerotherapy, laser or radiofrequency in an outpatient setting may help the ulcers to heal more quickly and reduce the chance of the ulcer recurrence. The aim of this study is to see whether early treatment of varicose veins using endovenous glue embolization helps with healing.

Conditions

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Venous Leg Ulcer

Keywords

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Venous Leg Ulcer Glue embolization saphenous vein reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The randomised clinical trial with participants randomised1:1 to either:

'Standard' therapy consisting of multilayer elastic compression bandaging/ stockings with deferred treatment of superficial reflux (usually once the ulcer has healed) Early endovenous glue embolization of superficial venous reflux(within 2 weeks) in addition to standard therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard therapy arm

Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)

Group Type ACTIVE_COMPARATOR

Standard therapy arm

Intervention Type PROCEDURE

Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)

Early endovenous glue embolization arm

Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy

Group Type EXPERIMENTAL

Early endovenous glue embolization arm

Intervention Type PROCEDURE

Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy

Interventions

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Standard therapy arm

Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)

Intervention Type PROCEDURE

Early endovenous glue embolization arm

Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Current leg ulceration of greater than 6 weeks, but less than 6 months duration
* Able to give informed consent to participate in the study after reading the patient information documentation
* Patient age \> 18 years
* Ankle Brachial Pressure Index (ABPI) ≥ 0.8
* 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)

Exclusion Criteria

* Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention
* Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
* The inability of the patient to receive the prompt endovenous intervention
* Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nuttawut Sermsathanasawadi, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Nuttawut Sermsathanasawadi,, MD

Role: CONTACT

Phone: 6624198021

Email: [email protected]

Nuttawut Sermsathanasawadi, MD

Role: CONTACT

Phone: 6624198021

Email: [email protected]

Facility Contacts

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Nuttawut Sermsathanasawadi, MD., Ph.D

Role: primary

Other Identifiers

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SI287/2560

Identifier Type: -

Identifier Source: org_study_id