Clinical trial NCT03640689: DEep VEin Lesion OPtimisation (DEVELOP) Trial
Official title: DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: Venous ulcer
Great saphenous incompetence
Iliac vein
Endovenous therapy
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Ulcer Healing - Proportion of ulcers healed
timeFrame: 3-months
measure: Iliac Vein Patency on duplex ultrasound
timeFrame: 6-months
measure: Reintervention
timeFrame: 12-months
Secondary outcomes:
measure: Ulcer healing - Time to ulcer healing
timeFrame: In days
measure: Patient Quality of life using the Aberdeen Varicose Vein Questionnaire
timeFrame: 12-months
measure: Recurrence - Ulcer recurrence
timeFrame: 12-months
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Soalta Hospital Group
city: Galway
country: Ireland
facility: Univsersity Hospital Galway
Study officials:
References:
citation: Aherne TM, Keohane C, Mullins M, Zafar AS, Black SA, Tang TY, O'Sullivan GJ, Walsh SR. DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers. Pilot Feasibility Stud. 2021 Feb 4;7(1):42. doi: 10.1186/s40814-021-00779-2.