DEep VEin Lesion OPtimisation (DEVELOP) Trial (Develop)

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland, 0000
    • Recruiting
    • Soalta Hospital Group
    • Contact: Thomas m Aherne, MBBCHBAO; Phone Number: 091542000; Email: thomasaherne@rcsi.com
    • Contact: Stewart R Walsh, MBBCHBAO
  • Galway, Ireland, 0000
    • Recruiting
    • Univsersity Hospital Galway
    • Contact: Thomas M Aherne, MBBChBAO, MCh; Phone Number: 091542000; Email: tommyaherne@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Venous ulcer; Great saphenous incompetence; Iliac vein; Endovenous therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: NUIreland1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: 1 year for 5 years
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes