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

Venous Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03666754
• Other study ID #: SI287/2560
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Mahidol University
• Contact: Nuttawut Sermsathanasawadi,, MD
• Phone: 6624198021
• Email: nutttawut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Procedure:
• Standard therapy arm
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

Locations

Country	Name	City	State
Thailand	Vascular Surgery, Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Quality Of Life SF36	Generic (SF36) quality of life assessment	6 weeks post randomisation, 6 months, 12 months
Secondary	Quality Of Life CIVIQ-20	CIVIQ-20 assessment	6 weeks post randomisation, 6 months, 12 months
Secondary	Quality Of Life EQ5D	Generic (EQ5D )quality of life assessment	6 weeks post randomisation, 6 months, 12 months
Secondary	Clinical Success - Presence of residual / recurrent varicose veins	The presence of residual / recurrent varicose veins remaining on the venous duplex	at 6 weeks
Secondary	Clinical Success - VCSS	The Venous Clinical Severity Score (VCSS)	at 6 weeks
Secondary	Clinical Success - Complications	Incidence of complications related to the endovenous intervention	up to 12 months