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

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

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

Study Overview

• Status: Recruiting
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Procedure: Standard therapy arm; Procedure: Early endovenous glue embolization arm

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nuttawut Sermsathanasawadi,, MD; Phone Number: 6624198021; Email: nutttawut@gmail.com
• Study Contact Backup: Name: Nuttawut Sermsathanasawadi, MD; Phone Number: 6624198021; Email: nutttawut@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Vascular Surgery, Siriraj Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard therapy arm; Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)	Procedure: Standard therapy arm; Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)
Experimental: Early endovenous glue embolization arm; Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy	Procedure: Early endovenous glue embolization arm; Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	time from date of randomisation to date of healing within the 12 month study period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 weeks & time to ulcer healing within the 12 month study period
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.	Up to 12 months
Quality Of Life SF36	Generic (SF36) quality of life assessment	6 weeks post randomisation, 6 months, 12 months
Quality Of Life CIVIQ-20	CIVIQ-20 assessment	6 weeks post randomisation, 6 months, 12 months
Quality Of Life EQ5D	Generic (EQ5D )quality of life assessment	6 weeks post randomisation, 6 months, 12 months
Clinical Success - Presence of residual / recurrent varicose veins	The presence of residual / recurrent varicose veins remaining on the venous duplex	at 6 weeks
Clinical Success - VCSS	The Venous Clinical Severity Score (VCSS)	at 6 weeks
Clinical Success - Complications	Incidence of complications related to the endovenous intervention	up to 12 months

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Nuttawut Sermsathanasawadi, MD, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Venous Leg Ulcer; Glue embolization; saphenous vein reflux
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: SI287/2560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No