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

Primary Purpose

Venous Leg Ulcer

Status

Recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Standard therapy arm

Early endovenous glue embolization arm

About this trial

This is an interventional treatment trial for Venous Leg Ulcer focused on measuring Venous Leg Ulcer, Glue embolization, saphenous vein reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Vascular Surgery, Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard therapy arm

Early endovenous glue embolization arm

Arm Description

Multilayer elastic compression bandaging/ stockings with the 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 compression therapy

Outcomes

Primary Outcome Measures

Time to ulcer healing

For the purposes of this study, ulcer healing is defined as complete re-epithelialization of all ulceration on the randomized (reference) leg in the absence of a scab (eschar) with no dressing required.

Secondary Outcome Measures

Ulcer Healing Rate

Healing rate will be reported at 24 weeks in addition to time to ulcer healing to allow comparison with other published studies

Ulcer recurrence / Ulcer Free Time

Will be calculated up to 1 year for each study arm to allow a very practical and easily understood assessment of the clinical difference between the 2 arms of the study. This will also allow comparison with other studies that have reported this outcome. In order to facilitate accurate calculation of reoccurrence/ulcer free time, clinical follow up will be continued after ulcer healing up to 1 year after randomization.

Quality Of Life SF36

Generic (SF36) quality of life assessment

Quality Of Life CIVIQ-20

CIVIQ-20 assessment

Quality Of Life EQ5D

Generic (EQ5D )quality of life assessment

Clinical Success - Presence of residual / recurrent varicose veins

The presence of residual / recurrent varicose veins remaining on the venous duplex

Clinical Success - VCSS

The Venous Clinical Severity Score (VCSS)

Clinical Success - Complications

Incidence of complications related to the endovenous intervention

Full Information

NCT ID

NCT03666754

First Posted

September 10, 2018

Last Updated

December 16, 2021

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT03666754

Brief Title

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

Official Title

The Effectiveness of Compression and Early Glue Ablation of Saphenous Vein Reflux Compared With Compression Alone in the Healing of Venous Ulcer, a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 26, 2018 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Venous Leg Ulcer

Keywords

Venous Leg Ulcer, Glue embolization, saphenous vein reflux

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard therapy arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

Early endovenous glue embolization arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Standard therapy arm

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Early endovenous glue embolization arm

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to ulcer healing

Description

Time Frame

time from date of randomisation to date of healing within the 12 month study period

Secondary Outcome Measure Information:

Title

Ulcer Healing Rate

Description

Healing rate will be reported at 24 weeks in addition to time to ulcer healing to allow comparison with other published studies

Time Frame

24 weeks & time to ulcer healing within the 12 month study period

Title

Ulcer recurrence / Ulcer Free Time

Description

Time Frame

Up to 12 months

Title

Quality Of Life SF36

Description

Generic (SF36) quality of life assessment

Time Frame

6 weeks post randomisation, 6 months, 12 months

Title

Quality Of Life CIVIQ-20

Description

CIVIQ-20 assessment

Time Frame

6 weeks post randomisation, 6 months, 12 months

Title

Quality Of Life EQ5D

Description

Generic (EQ5D )quality of life assessment

Time Frame

6 weeks post randomisation, 6 months, 12 months

Title

Clinical Success - Presence of residual / recurrent varicose veins

Description

The presence of residual / recurrent varicose veins remaining on the venous duplex

Time Frame

at 6 weeks

Title

Clinical Success - VCSS

Description

The Venous Clinical Severity Score (VCSS)

Time Frame

at 6 weeks

Title

Clinical Success - Complications

Description

Incidence of complications related to the endovenous intervention

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nuttawut Sermsathanasawadi,, MD

Phone

6624198021

nutttawut@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Nuttawut Sermsathanasawadi, MD

Phone

6624198021

nutttawut@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nuttawut Sermsathanasawadi, MD

Organizational Affiliation

Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vascular Surgery, Siriraj Hospital, Mahidol University

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nuttawut Sermsathanasawadi, MD., Ph.D

Phone

+6624198021

nutttawut@gmail.com

First Name & Middle Initial & Last Name & Degree

Nuttawut Sermsathanasawadi, MD., Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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