{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,11]],"date-time":"2025-12-11T21:04:07Z","timestamp":1765487047372,"version":"build-2065373602"},"reference-count":8,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T00:00:00Z","timestamp":1708560000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["International Wound Journal"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>We report the first clinical evaluation of a new enzymatic wound debridement product containing tarumase in venous leg ulcer patients. As a first\u2010in\u2010human study, this was a prospective, open\u2010label, multi\u2010centre, dose escalation study across five dose cohorts and involving a total of 43 patients treated three times weekly for up to 4\u2009weeks (12 applications). The primary and secondary endpoints of the study were to assess the systemic safety, local tolerability, and early proof of concept both for wound debridement and healing. Results indicated that the tarumase enzyme was well tolerated when applied topically to wounds, with no indications of systemic absorption, no evidence of antibody generation, and no systemic effects on coagulation pathways. Locally, there was no evidence of pain on application, no local itching, no increases in erythema, oedema, exudate or bleeding and only a few treatment emergent adverse events were reported. As the concentration of tarumase was escalated, trends towards faster and improved effectiveness of wound debridement were observed, especially in patients with significant slough at baseline. Trends towards faster rates of healing were also noted based on observations of increased granulation tissue, increased linear healing and reduction in surface area over the 4\u2010week treatment period.<\/jats:p>","DOI":"10.1111\/iwj.14805","type":"journal-article","created":{"date-parts":[[2024,2,22]],"date-time":"2024-02-22T09:47:55Z","timestamp":1708595275000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers"],"prefix":"10.1111","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3675-2437","authenticated-orcid":false,"given":"David M.","family":"Fairlamb","sequence":"first","affiliation":[{"name":"SolasCure Limited, Wellington House  Cambridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3711-0131","authenticated-orcid":false,"given":"Kinga","family":"Szepeshazi","sequence":"additional","affiliation":[{"name":"SolasCure Limited, Wellington House  Cambridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4349-9193","authenticated-orcid":false,"given":"David","family":"Goldsmith","sequence":"additional","affiliation":[{"name":"SolasCure Limited, Wellington House  Cambridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-3809-1588","authenticated-orcid":false,"given":"Peter","family":"Danos","sequence":"additional","affiliation":[{"name":"\u00d3budai Eg\u00e9szs\u00e9g\u00fcgyi Centrum (OEC) KFT  Budapest Hungary"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6223-7001","authenticated-orcid":false,"given":"Hadar","family":"Lev\u2010Tov","sequence":"additional","affiliation":[{"name":"Dermatology Clinical Trial Unit University of Miami Hospital  Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3086-244X","authenticated-orcid":false,"given":"Nathan","family":"Young","sequence":"additional","affiliation":[{"name":"Foot and Ankle Specialist of the MidAtlantic  Salem Virginia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9369-0885","authenticated-orcid":false,"given":"Jason","family":"Hanft","sequence":"additional","affiliation":[{"name":"Doctors Research Network  Miami Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5682-7056","authenticated-orcid":false,"given":"Charles","family":"Zelen","sequence":"additional","affiliation":[{"name":"Professional Education &amp; Research Institute LLC [PERI]  Roanoke Virginia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,2,22]]},"reference":[{"doi-asserted-by":"publisher","key":"e_1_2_9_2_1","DOI":"10.1111\/iwj.14079"},{"doi-asserted-by":"publisher","key":"e_1_2_9_3_1","DOI":"10.1038\/s41572-022-00377-3"},{"doi-asserted-by":"publisher","key":"e_1_2_9_4_1","DOI":"10.1097\/01.ASW.0000733724.87630.d6"},{"doi-asserted-by":"publisher","key":"e_1_2_9_5_1","DOI":"10.1016\/j.amsu.2021.102876"},{"issue":"2","key":"e_1_2_9_6_1","article-title":"Permissive maintenance debridement\u2014the role of enzymatic debridement in chronic wound care","volume":"8","author":"Lantis J","year":"2017","journal-title":"Wounds Int"},{"key":"e_1_2_9_7_1","first-page":"95","article-title":"Parameter for measurement of wound closure","volume":"2","author":"Gilman T","year":"1990","journal-title":"Wounds"},{"doi-asserted-by":"publisher","key":"e_1_2_9_8_1","DOI":"10.3389\/fbioe.2019.00342"},{"doi-asserted-by":"publisher","key":"e_1_2_9_9_1","DOI":"10.7326\/AITC201608020"}],"container-title":["International Wound Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/iwj.14805","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T15:41:27Z","timestamp":1759246887000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/iwj.14805"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2,22]]},"references-count":8,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,3]]}},"alternative-id":["10.1111\/iwj.14805"],"URL":"https:\/\/doi.org\/10.1111\/iwj.14805","archive":["Portico"],"relation":{},"ISSN":["1742-4801","1742-481X"],"issn-type":[{"type":"print","value":"1742-4801"},{"type":"electronic","value":"1742-481X"}],"subject":[],"published":{"date-parts":[[2024,2,22]]},"assertion":[{"value":"2023-12-18","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-06","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e14805"}}