{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T17:07:34Z","timestamp":1780506454257,"version":"3.54.1"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,2,4]],"date-time":"2021-02-04T00:00:00Z","timestamp":1612396800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,2,4]],"date-time":"2021-02-04T00:00:00Z","timestamp":1612396800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pilot Feasibility Stud"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Venous leg ulceration is a widespread, debilitating pathology with high recurrence rates. Conservative treatment using graduated compression dressings may be associated with unacceptable ulcer recurrence rates. Early superficial venous ablation encourages ulcer healing and reduces recurrence. However, many of this cohort display concomitant ilio-caval stenosis, which further contributes to lower limb venous hypertension and ulceration.<\/jats:p>\n                    <jats:p>An approach that combines early superficial venous ablation with early treatment of ilio-caval stenotic disease may significantly improve ulcer healing and recurrence rates. We question whether early iliac vein interrogation with intravascular ultrasound (IVUS), stenting of significant occlusive disease plus superficial venous ablation, in patients with active venous leg ulceration, will produce superior ulcer healing to standard therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a prospective, multi-centre, randomised controlled, feasibility trial recruiting patients with lower limb venous ulceration and saphenous venous 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 (&gt;\u200950%) iliac vein lesions plus compression therapy. The primary feasibility outcome will be the rate of eligible patient participation while the primary clinical outcomes will be ulcer healing and procedural safety. Secondary outcomes 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 5-year period. This feasibility trial is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the trial to definitively address ulcer-healing rates.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This trial will be the first randomised trial to examine the role iliac interrogation and intervention in conjunction with standard operative therapy in the management of venous ulceration related to superficial truncal venous incompetence.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethical committee reference<\/jats:title>\n                    <jats:p>C.A. 2111 Galway Clinical Research Ethics Committee<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Registration<\/jats:title>\n                    <jats:p>\n                      Clinical Trials.gov registration\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03640689\">NCT03640689<\/jats:ext-link>\n                      , Registered on 21 August 2018.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s40814-021-00779-2","type":"journal-article","created":{"date-parts":[[2021,2,4]],"date-time":"2021-02-04T03:04:11Z","timestamp":1612407851000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers"],"prefix":"10.1186","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7098-4269","authenticated-orcid":false,"given":"Thomas M.","family":"Aherne","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colm","family":"Keohane","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Mullins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adeel S.","family":"Zafar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen A.","family":"Black","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tjun Y.","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerard J.","family":"O\u2019Sullivan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stewart R.","family":"Walsh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,2,4]]},"reference":[{"issue":"4","key":"779_CR1","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1111\/j.1742-481X.2012.01108.x","volume":"11","author":"M Clarke-Moloney","year":"2012","unstructured":"Clarke-Moloney M, Keane N, O\u2019Connor V, Ryan MA, Meagher H, Grace PA, et al. Randomised controlled trial comparing European standard class 1 to class 2 compression stockings for ulcer recurrence and patient compliance. Int Wound J. 2012;11(4):404\u20138.","journal-title":"Int Wound J"},{"issue":"2","key":"779_CR2","doi-asserted-by":"publisher","first-page":"110","DOI":"10.1007\/BF03166911","volume":"169","author":"JF O\u2019Brien","year":"2000","unstructured":"O\u2019Brien JF, Grace PA, Perry IJ, Burke PE. Prevalence and Aetiology of leg ulcers in Ireland. Irish J Med Sci. 2000;169(2):110\u20132.","journal-title":"Irish J Med Sci"},{"key":"779_CR3","doi-asserted-by":"publisher","first-page":"223","DOI":"10.1177\/026835559000500403","volume":"5","author":"CC Michael","year":"1990","unstructured":"Michael CC. Oxygen diffusion in oedematous tissue and through pericapillary cuffs. 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J Vasc Surg Venous Lymphat Disord. 2017;5(5):678\u201387.","journal-title":"J Vasc Surg Venous Lymphat Disord"}],"container-title":["Pilot and Feasibility Studies"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s40814-021-00779-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s40814-021-00779-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s40814-021-00779-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,4]],"date-time":"2021-02-04T03:07:25Z","timestamp":1612408045000},"score":1,"resource":{"primary":{"URL":"https:\/\/pilotfeasibilitystudies.biomedcentral.com\/articles\/10.1186\/s40814-021-00779-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2,4]]},"references-count":27,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["779"],"URL":"https:\/\/doi.org\/10.1186\/s40814-021-00779-2","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.2.314\/v3","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.314\/v1","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.2.314\/v2","asserted-by":"object"}]},"ISSN":["2055-5784"],"issn-type":[{"value":"2055-5784","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,2,4]]},"assertion":[{"value":"30 September 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 January 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 February 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Ethical approval has been granted by the Galway Clinical Research Ethics Committee Galway, Ireland. Ethics reference number C.A.2111. Consent will be sought from each individual participant prior to inclusion. Full verbal and written information will be provided. Participants reserve the right to refuse with no reason provided and this will not bias their treatment. Participants are free to withdraw at any time.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Consent for publication shall be sought during the initial participant consent process for trial inclusion (Additional file\n                      \n                      ).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"42"}}