DEep VEin Lesion OPtimisation (DEVELOP) Trial (Develop)

National University of Ireland, Galway, Ireland

Status: Enrolling

Conditions: Venous Leg Ulcer

Treatments: Device: Endovenous ablation + iliac US +/- iliac stenting; Device: Endovenous ablation of Great Saphenous Vein

Study type: Interventional

Funder types: Other

Identifiers

NCT03640689

NUIreland1

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Endovenous ablation + iliac US +/- iliac stenting

Treatment:

Device: Endovenous ablation + iliac US +/- iliac stenting

Control Group

Active Comparator group

Description:

Endovenous ablation of Great Saphenous Vein

Treatment:

Device: Endovenous ablation of Great Saphenous Vein