Venous Leg Ulcer
Conditions
Keywords
Venous Leg Ulcer, Glue embolization, saphenous vein reflux
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.
Interventions
PROCEDUREStandard therapy arm
Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)
PROCEDUREEarly endovenous glue embolization arm
Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to ulcer healing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer recurrence / Ulcer Free Time | Up to 12 months | 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. |
| Quality Of Life SF36 | 6 weeks post randomisation, 6 months, 12 months | Generic (SF36) quality of life assessment |
| Quality Of Life CIVIQ-20 | 6 weeks post randomisation, 6 months, 12 months | CIVIQ-20 assessment |
| Ulcer Healing Rate | 24 weeks & time to ulcer healing within the 12 month study period | Healing rate will be reported at 24 weeks in addition to time to ulcer healing to allow comparison with other published studies |
| Clinical Success - Presence of residual / recurrent varicose veins | at 6 weeks | The presence of residual / recurrent varicose veins remaining on the venous duplex |
| Clinical Success - VCSS | at 6 weeks | The Venous Clinical Severity Score (VCSS) |
| Clinical Success - Complications | up to 12 months | Incidence of complications related to the endovenous intervention |
| Quality Of Life EQ5D | 6 weeks post randomisation, 6 months, 12 months | Generic (EQ5D )quality of life assessment |
Countries
Thailand
Contacts
Primary ContactNuttawut Sermsathanasawadi,, MD
Backup ContactNuttawut Sermsathanasawadi, MD
Outcome results
None listed