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

Mahidol University

Status: Unknown

Conditions: Venous Leg Ulcer

Treatments: Procedure: Standard therapy arm; Procedure: Early endovenous glue embolization arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03666754

SI287/2560

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Standard therapy arm

Active Comparator group

Description:

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

Treatment:

Procedure: Standard therapy arm

Early endovenous glue embolization arm

Experimental group

Description:

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

Treatment:

Procedure: Early endovenous glue embolization arm