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Develop: DEep VEin Lesion OPtimisation (DEVELOP) Trial

Sponsor
National University of Ireland, Galway, Ireland (Other)
Overall Status
Recruiting
CT.gov ID
NCT03640689
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
61.6
Anticipated Duration (Months)
30
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Endovenous ablation + iliac US +/- iliac stenting
  • Device: Endovenous ablation of Great Saphenous Vein
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
DEep VEin Lesion OPtimisation (DEVELOP) Trial: A Randomised, Assessor-blinded Feasibility Study of Iliac Vein Intervention for Venous Leg Ulcers
Actual Study Start Date :
Jul 15, 2019
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ulcer Healing - Proportion of ulcers healed [3-months]

      Proportion of ulcers healed

    2. Iliac Vein Patency on duplex ultrasound [6-months]

      Patency of the iliac vein on duplex

    3. Reintervention [12-months]

      Freedom from re-intervention

    Secondary Outcome Measures

    1. Ulcer healing - Time to ulcer healing [In days]

      Time to ulcer healing

    2. 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.

    3. Recurrence - Ulcer recurrence [12-months]

      Ulcer recurrence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soalta Hospital Group Galway Ireland 0000
    2 Univsersity Hospital Galway Galway Ireland 0000

    Sponsors and Collaborators

    • National University of Ireland, Galway, Ireland

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Aherne, Principle Investigator Dr Thomas Aherne, National University of Ireland, Galway, Ireland
    ClinicalTrials.gov Identifier:
    NCT03640689
    Other Study ID Numbers:
    • NUIreland1
    First Posted:
    Aug 21, 2018
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by Thomas Aherne, Principle Investigator Dr Thomas Aherne, National University of Ireland, Galway, Ireland
    Venous ulcer
    Great saphenous incompetence
    Iliac vein
    Endovenous therapy
    Additional relevant MeSH terms:
    Varicose Ulcer
    Leg Ulcer
    Ulcer

    Study Results

    No Results Posted as of Mar 3, 2021