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NCT03640689: Develop
DEep VEin Lesion OPtimisation (DEVELOP) Trial
NA trial testing Endovenous ablation + iliac US +/- iliac stenting in Venous Leg Ulcer in 60 participants. Status unknown.
1 September 2024
Quick facts
| Lead sponsor | National University of Ireland, Galway, Ireland |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 15 July 2019 |
| Primary completion | 1 September 2024 |
| Estimated completion | 1 September 2024 |
| Sites | 2 locations across Ireland |
Drugs / interventions tested
- Endovenous ablation + iliac US +/- iliac stenting
- Endovenous ablation of Great Saphenous Vein
Conditions studied
- Venous Leg Ulcer — all drugs for Venous Leg Ulcer →
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):
-
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 -
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:
- PubMed search for NCT03640689
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National University of Ireland, Galway, Ireland trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03640689 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University of Ireland, Galway, Ireland
- Last refreshed: 3 March 2021
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