Venous Leg Ulcer
Conditions
Keywords
Venous ulcer, Great saphenous incompetence, Iliac vein, Endovenous therapy
Brief summary
This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with lower limb venous ulceration and Great Saphenous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (\>50%) iliac vein lesions plus compression therapy. The primary endpoints will be ulcer healing and procedural safety. Secondary endpoints include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow up will be over a five-year period. This feasibility study is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the study to definitively address ulcer-healing rates.
Detailed description
The single main research question for this trial is as follows: in adult patients with venous ulceration and great saphenous vein incompetence; does iliac vein assessment with IVUS and stenting of significant occlusive disease in addition to superficial great saphenous venous ablation and compression compared to superficial venous ablation and compression alone offer improved ulcer healing rates at three months following treatment? Primary Objective To determine whether superficial venous ablation plus early iliac vein interrogation plus endovascular stenting in the presence of significant occlusive disease results in improved venous ulcer healing compared to superficial venous ablation plus compression therapy alone. Secondary Objectives 1\. To determine the relative performance of duplex ultrasound compared to IVUS for the prediction of NIVLs 3. To determine the rate of primary or recurrent ulceration up to five years following intervention 4. To assess patient quality of life in the short and medium term following each mode of intervention
Interventions
DEVICEEndovenous ablation + iliac US +/- iliac stenting
Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required
DEVICEEndovenous ablation of Great Saphenous Vein
Ablation of the Great Saphenous Vein and subsequent Graduated Compression
Sponsors
National University of Ireland, Galway, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Consenting patients * aged 18 and over * ultrasound detected Great Saphenous Venous incompetence * an associated primary or recurrent lower limb venous ulcer(s)
Exclusion criteria
* Ankle-brachial pressure index \<0.8 * Previous inability to tolerate lower limb compression bandaging * Inability to provide informed consent * Previous lower limb arterial revascularisation procedure * Contrast allergy * Previous history of pelvic malignancy or pelvic radiotherapy * Pregnancy * Previous iliac vein intervention * Previous superficial vein intervention * Infection in previous 30 days * Estimated glomerular filtration rate (eGFR) \< 60 mls/kg/min * Isolated short saphenous or perforator vein reflux only * Leg ulcer of non-venous aetiology (as assessed by clinician) * Unfit for endovascular intervention based on history and examination * Any compression therapy within six-months * Evidence of deep venous incompetence/thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Healing - Proportion of ulcers healed | 3-months | Proportion of ulcers healed |
| Iliac Vein Patency on duplex ultrasound | 6-months | Patency of the iliac vein on duplex |
| Reintervention | 12-months | Freedom from re-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer healing - Time to ulcer healing | In days | Time to ulcer healing |
| Patient Quality of life using the Aberdeen Varicose Vein Questionnaire | 12-months | Aberdeen Varicose Vein Questionnaire measured from 0(no effect)-100(severe effect). The higher the score the greater the negative impact on patient quality of life. |
| Recurrence - Ulcer recurrence | 12-months | Ulcer recurrence |
Countries
Ireland
Outcome results
None listed