DEep VEin Lesion OPtimisation (DEVELOP) Trial

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcer
• Interventions: Device: Endovenous ablation + iliac US +/- iliac stenting; Device: Endovenous ablation of Great Saphenous Vein

• Registration Number: NCT03640689
• Lead Sponsor: National University of Ireland, Galway, Ireland

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

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-21
• Study Start: 2019-07-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Endovenous ablation + iliac US +/- iliac stenting	Endovenous ablation + iliac US +/- iliac stenting
Control Group	Endovenous ablation of Great Saphenous Vein	Endovenous ablation of Great Saphenous Vein

Primary Outcome Measures

Name	Time	Method
Iliac Vein Patency on duplex ultrasound	6-months	Patency of the iliac vein on duplex
Ulcer Healing - Proportion of ulcers healed	3-months	Proportion of ulcers healed
Reintervention	12-months	Freedom from re-intervention

Secondary Outcome Measures

Name	Time	Method
Recurrence - Ulcer recurrence	12-months	Ulcer recurrence
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.
Ulcer healing - Time to ulcer healing	In days	Time to ulcer healing

Trial Locations

Locations (2)

Soalta Hospital Group; 🇮🇪 Galway, Ireland

Univsersity Hospital Galway; 🇮🇪 Galway, Ireland