DEep VEin Lesion OPtimisation (DEVELOP) Trial Study protocol for a randomised, assessor-blinded feasibility study of iliac vein intervention for venous leg ulcers

Abstract

Background: Venous leg ulceration is a widespread, debilitating pathology with high recurrence rates. Conservative treatment using graduated compression dressings may be associated with unacceptable ulcer recurrence rates. Early superficial venous ablation encourages ulcer healing and reduces recurrence. However, many of this cohort display concomitant ilio-caval stenosis, which further contributes to lower limb venous hypertension and ulceration. An approach which combines early superficial venous ablation with early treatment of ilio-caval stenotic disease may significantly improve ulcer healing and recurrence rates. We question whether early iliac vein interrogation with intravascular ultrasound (IVUS), stenting of significant occlusive disease plus superficial venous ablation, in patients with active venous leg ulceration, will produce superior ulcer healing to standard therapy. Methods: This is a prospective, multi-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. Discussion: This study will be the first randomised trial to examine the role iliac interrogation and intervention in conjunction with standard operative therapy in the management of venous ulceration related to Great Saphenous incompetence. Ethical Committee Reference: C.A. 2111 Galway Clinical Research Ethics Comittee. Registration: Clinical Trials.gov registration NCT03640689 , Registered 21/08/2018, https://clinicaltrials.gov/ct2/show/NCT03640689. Keywords: Venous ulcer, endovenous, deep venous intervention, iliac vein, intra-vascular ultrasound, great saphenous incompetence.