Venous Leg UlcerNCT03666754
Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer
A study testing Standard therapy arm and Early endovenous glue embolization arm in people with Venous Leg Ulcer, run by Mahidol University at 1 site in Thailand.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Standard therapy arm and Early endovenous glue embolization arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 26 Sep 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
Nuttawut Sermsathanasawadi, MD., Ph.D, +6624198021, nutttawut@gmail.com
Nuttawut Sermsathanasawadi, MD., Ph.D
About this study
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
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
Read the 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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Standard therapy arm, Early endovenous glue embolization arm
- Keywords
- Venous Leg Ulcer, Glue embolization, saphenous vein reflux
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard therapy armProcedure or surgery
Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)
Early endovenous glue embolization armProcedure or surgery
Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy arm | Active comparator | Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed) Receives: 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 Receives: Procedure: Early endovenous glue embolization arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: time from date of randomisation to date of healing within the 12 month study period
Secondary outcomes (8)
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
Measured: 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.
Measured: Up to 12 months
Quality Of Life SF36
Generic (SF36) quality of life assessment
Measured: 6 weeks post randomisation, 6 months, 12 months
Quality Of Life CIVIQ-20
CIVIQ-20 assessment
Measured: 6 weeks post randomisation, 6 months, 12 months
Quality Of Life EQ5D
Generic (EQ5D )quality of life assessment
Measured: 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
Measured: at 6 weeks
Clinical Success - VCSS
The Venous Clinical Severity Score (VCSS)
Measured: at 6 weeks
Clinical Success - Complications
Incidence of complications related to the endovenous intervention
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start26 Sep 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuttawut Sermsathanasawadi, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666754
- Sponsor's protocol ID
- SI287/2560
- Status last verified
- Dec 2021
- First submitted
- 10 Sep 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03666754
- Acronym / sponsor ID
- SI287/2560
- Conditions
- Venous Leg Ulcer
- Keywords
- Venous Leg Ulcer, Glue embolization, saphenous vein reflux
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard therapy arm | Active comparator | Procedure: Standard therapy armMultilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed) |
| Early endovenous glue embolization arm | Experimental | Procedure: Early endovenous glue embolization armEarly endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard therapy armMultilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed) | Procedure or surgery | Standard therapy arm |
| Early endovenous glue embolization armEarly endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy | Procedure or surgery | Early endovenous glue embolization arm |
Primary outcome
Time to ulcer healing
Time frame: time from date of randomisation to date of healing within the 12 month study period
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.
8 secondary outcomes
Ulcer Healing Rate
Time frame: 24 weeks & time to ulcer healing within the 12 month study period
Ulcer recurrence / Ulcer Free Time
Time frame: Up to 12 months
Quality Of Life SF36
Time frame: 6 weeks post randomisation, 6 months, 12 months
Quality Of Life CIVIQ-20
Time frame: 6 weeks post randomisation, 6 months, 12 months
Quality Of Life EQ5D
Time frame: 6 weeks post randomisation, 6 months, 12 months
Clinical Success - Presence of residual / recurrent varicose veins
Time frame: at 6 weeks
Clinical Success - VCSS
Time frame: at 6 weeks
Clinical Success - Complications
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuttawut Sermsathanasawadi, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard therapy arm and Early endovenous glue embolization arm in people with Venous Leg Ulcer, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuttawut Sermsathanasawadi,, MD (6624198021, nutttawut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to ulcer healing (time frame: time from date of randomisation to date of healing within the 12 month study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.