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NCT03640689: Develop

DEep VEin Lesion OPtimisation (DEVELOP) Trial

Status unknown NA Last updated 3 March 2021
What this trial tests

NA trial testing Endovenous ablation + iliac US +/- iliac stenting in Venous Leg Ulcer in 60 participants. Status unknown.

Timeline
15 July 2019
Primary endpoint
1 September 2024
1 September 2024

Quick facts

Lead sponsorNational University of Ireland, Galway, Ireland
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposediagnostic
Enrollment60
Start date15 July 2019
Primary completion1 September 2024
Estimated completion1 September 2024
Sites2 locations across Ireland

Drugs / interventions tested

Conditions studied

Sponsor

National University of Ireland, Galway, Ireland

Who can join

18 and older, any sex, with Venous Leg Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers.
    Aherne TM, Keohane C, Mullins M, Zafar AS, et al · · 2021 · cited 4× · PMID 33541436 · DOI 10.1186/s40814-021-00779-2
  2. DEep VEin Lesion OPtimisation (DEVELOP) Trial. Protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers
    Aherne TM, Keohane C, Mullins M, Black SA, et al · · 2019 · DOI 10.21203/rs.2.314/v3

Verify or expand the search:

Other recruiting trials for Venous Leg Ulcer

Currently open trials in the same condition.

Other National University of Ireland, Galway, Ireland trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03640689.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing