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We introduce a new proof\u2010of\u2010concept strategy to a<jats:styled-content style=\"fixed-case\">VLU<\/jats:styled-content>clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus<jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>for success in future randomised, controlled clinical trials. Prospective data on chronic<jats:styled-content style=\"fixed-case\">VLUs<\/jats:styled-content>from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the<jats:styled-content style=\"fixed-case\">UK<\/jats:styled-content>(17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score\u2010matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi\u2010layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow\u2010up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the<jats:styled-content style=\"fixed-case\">UK<\/jats:styled-content>(the comparison group;<jats:styled-content style=\"fixed-case\">VLU<\/jats:styled-content>evidence network). Analysis using Kaplan\u2013Meier survival curves showed a mean healing time of 73\u00b71 days for<jats:styled-content style=\"fixed-case\">ASM<\/jats:styled-content>plus<jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>(<jats:styled-content style=\"fixed-case\">ASM<\/jats:styled-content>) treated ulcers in comparison with 83\u00b75 days for comparison group ulcers treated with<jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>alone (Log rank test,<jats:italic>\u03c7<\/jats:italic><jats:sup>2<\/jats:sup>5\u00b7779,<jats:italic>P<\/jats:italic>\u2009=\u20090\u00b7016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for<jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>by a factor of 1\u00b71 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new<jats:styled-content style=\"fixed-case\">ASM<\/jats:styled-content>as an adjunct to<jats:styled-content style=\"fixed-case\">SC<\/jats:styled-content>in the treatment of non\u2010healing venous ulcers in the<jats:styled-content style=\"fixed-case\">UK<\/jats:styled-content>, but results are sensitive to unobserved covariates that may be important in healing time comparison.<\/jats:p>","DOI":"10.1111\/iwj.12687","type":"journal-article","created":{"date-parts":[[2016,11,21]],"date-time":"2016-11-21T04:32:48Z","timestamp":1479702768000},"page":"729-741","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["A single\u2010arm trial indirect comparison investigation: a proof\u2010of\u2010concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control"],"prefix":"10.1111","volume":"14","author":[{"given":"Ronald","family":"Shannon","sequence":"first","affiliation":[{"name":"Global Health Economic Projects LLC Clifton Park NY USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Nelson","sequence":"additional","affiliation":[{"name":"Head of School, School of Healthcare University of Leeds Leeds UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,11,20]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1610-0387.2010.07535.x"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2009.00543.x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.2003.05222.x"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2007.00250.x"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c6045"},{"key":"e_1_2_7_7_1","first-page":"44","article-title":"The burden of chronic wounds in the UK","volume":"104","author":"Posnett J","year":"2008","journal-title":"Nurs Times"},{"key":"e_1_2_7_8_1","first-page":"CD000265","article-title":"Compression for venous leg ulcers","volume":"1","author":"O'Meara S","year":"2009","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra055289"},{"key":"e_1_2_7_10_1","first-page":"989","article-title":"Diagnosis and treatment of venous ulcers","volume":"81","author":"Collins L","year":"2010","journal-title":"Am Fam Physician"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.7748\/phc2008.03.18.2.40.c6514"},{"key":"e_1_2_7_12_1","first-page":"58","article-title":"Deconstructing the stalled wound","volume":"24","author":"Widgerow AD","year":"2012","journal-title":"Wounds"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/0955-0674(95)80112-X"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1126\/scisignal.3126pl1"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1524-475X.1997.50108.x"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-475X.2011.00673.x"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1177\/1531003510373660"},{"key":"e_1_2_7_18_1","unstructured":"LazarusG ValleF MalasM QaziU MaruthurN ZenilmanJ BoultC DoggettD FawoleOA. 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