DEep VEin Lesion OPtimisation (DEVELOP) Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Endovenous ablation + iliac US +/- iliac stenting
* Device: Endovenous ablation of Great Saphenous Vein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Endovenous ablation + iliac US +/- iliac stenting | Device: Endovenous ablation + iliac US +/- iliac stenting<br>* Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required<br>* Other names: Iliac vein stenting;|
| Active Comparator: Control Group<br>Endovenous ablation of Great Saphenous Vein | Device: Endovenous ablation of Great Saphenous Vein<br>* Ablation of the Great Saphenous Vein and subsequent Graduated Compression<br>* Other names: Graduated Compression Stockings;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer Healing - Proportion of ulcers healed | Proportion of ulcers healed | 3-months | 
| Iliac Vein Patency on duplex ultrasound | Patency of the iliac vein on duplex | 6-months | 
| Reintervention | Freedom from re-intervention | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer healing - Time to ulcer healing | Time to ulcer healing | In days | 
| Patient Quality of life using the Aberdeen Varicose Vein Questionnaire | 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. | 12-months | 
| Recurrence - Ulcer recurrence | Ulcer recurrence | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous ulcer, Great saphenous incompetence, Iliac vein, Endovenous therapy