Clinical trial NCT03666754: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: Venous Leg Ulcer
Glue embolization
saphenous vein reflux
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Time to ulcer healing
timeFrame: time from date of randomisation to date of healing within the 12 month study period
Secondary outcomes:
measure: Ulcer Healing Rate
timeFrame: 24 weeks & time to ulcer healing within the 12 month study period
measure: Ulcer recurrence / Ulcer Free Time
timeFrame: Up to 12 months
measure: Quality Of Life SF36
timeFrame: 6 weeks post randomisation, 6 months, 12 months
measure: Quality Of Life CIVIQ-20
timeFrame: 6 weeks post randomisation, 6 months, 12 months
measure: Quality Of Life EQ5D
timeFrame: 6 weeks post randomisation, 6 months, 12 months
measure: Clinical Success - Presence of residual / recurrent varicose veins
timeFrame: at 6 weeks
measure: Clinical Success - VCSS
timeFrame: at 6 weeks
measure: Clinical Success - Complications
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Vascular Surgery, Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Nuttawut Sermsathanasawadi, MD
role: PRINCIPAL_INVESTIGATOR
References: