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

NCT03666754 | Unknown

• 1 other identifier: SI287/2560
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Venous Leg Ulcer

Keywords

Venous Leg Ulcer; Glue embolization; saphenous vein reflux

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ulcer Healing Rate

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

• Ulcer recurrence / Ulcer Free Time

  Up to 12 months

• Quality Of Life SF36

  6 weeks post randomisation, 6 months, 12 months

• Quality Of Life CIVIQ-20

  6 weeks post randomisation, 6 months, 12 months

• Quality Of Life EQ5D

  6 weeks post randomisation, 6 months, 12 months

Study Arms (2)

Standard therapy arm

ACTIVE COMPARATOR

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

Procedure: Standard therapy arm

Early endovenous glue embolization arm

EXPERIMENTAL

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

Procedure: Early endovenous glue embolization arm

Interventions

Standard therapy arm PROCEDURE

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

Standard therapy arm

Early endovenous glue embolization arm PROCEDURE

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

Early endovenous glue embolization arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nuttawut Sermsathanasawadi, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuttawut Sermsathanasawadi,, MD

CONTACT

6624198021; nutttawut@gmail.com

Nuttawut Sermsathanasawadi, MD

CONTACT

6624198021; nutttawut@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: September 26, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

TH (1)