DEep VEin Lesion OPtimisation (DEVELOP) Trial

NCT03640689 | Unknown FDA Device

• 1 other identifier: NUIreland1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Leg Ulcer

Keywords

Venous ulcer; Great saphenous incompetence; Iliac vein; Endovenous therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Ulcer healing - Time to ulcer healing

  In days

• Patient Quality of life using the Aberdeen Varicose Vein Questionnaire

  12-months

• Recurrence - Ulcer recurrence

  12-months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Endovenous ablation + iliac US +/- iliac stenting

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

Control Group

ACTIVE COMPARATOR

Endovenous ablation of Great Saphenous Vein

Device: Endovenous ablation of Great Saphenous Vein

Interventions

Endovenous ablation + iliac US +/- iliac stenting DEVICE

Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required

Also known as: Graduated Compression Stockings, Iliac vein intravascular ultrasound, Iliac vein stenting

Intervention Group

Endovenous ablation of Great Saphenous Vein DEVICE

Ablation of the Great Saphenous Vein and subsequent Graduated Compression

Also known as: Graduated Compression Stockings

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients
• aged 18 and over
• ultrasound detected Great Saphenous Venous incompetence
• an associated primary or recurrent lower limb venous ulcer(s)

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

Study Sites (2)

Soalta Hospital Group

Galway, 0000, Ireland

RECRUITING

Univsersity Hospital Galway

Galway, 0000, Ireland

RECRUITING

Related Publications (1)

• 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.

  PMID: 33541436 DERIVED

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator Dr Thomas Aherne

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: July 15, 2019
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year for 5 years

Locations

IE (2)