{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T05:32:37Z","timestamp":1784179957506,"version":"3.55.0"},"reference-count":42,"publisher":"Elsevier BV","issue":"9","license":[{"start":{"date-parts":[[2012,12,1]],"date-time":"2012-12-01T00:00:00Z","timestamp":1354320000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Seminars in Cell & Developmental Biology"],"published-print":{"date-parts":[[2012,12]]},"DOI":"10.1016\/j.semcdb.2012.09.014","type":"journal-article","created":{"date-parts":[[2012,10,9]],"date-time":"2012-10-09T21:37:49Z","timestamp":1349818669000},"page":"993-999","source":"Crossref","is-referenced-by-count":37,"title":["The FDA and designing clinical trials for chronic cutaneous ulcers"],"prefix":"10.1016","volume":"23","author":[{"given":"Andrea D.","family":"Maderal","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandra C.","family":"Vivas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William H.","family":"Eaglstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert S.","family":"Kirsner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.semcdb.2012.09.014_bib0005","unstructured":"Development and approval process (drugs). http:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/default.htm [accessed 31.03.12]."},{"key":"10.1016\/j.semcdb.2012.09.014_bib0010","unstructured":"Drugs@FDA glossary of terms. http:\/\/www.fda.gov\/Drugs\/InformationOnDrugs\/ucm079436.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=definition%20drug&utm_content=1#D [accessed 25.04.12]."},{"key":"10.1016\/j.semcdb.2012.09.014_bib0015","unstructured":"Is the product a medical device? http:\/\/www.fda.gov\/MedicalDevices\/DeviceRegulationandGuidance\/Overview\/ClassifyYourDevice\/ucm051512.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=definition%20medical%20device&utm_content=1 [accessed 25.04.12]."},{"key":"10.1016\/j.semcdb.2012.09.014_bib0020","unstructured":"FDA medical device approval process. http:\/\/www.mannfbe.org\/commercialize\/approval-process.htm [accessed 25.04.12]."},{"key":"10.1016\/j.semcdb.2012.09.014_bib0025","unstructured":"FDA: 35 innovated new drugs approved in fiscal year. http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm278383.htm [accessed 26.04.12]."},{"issue":"5","key":"10.1016\/j.semcdb.2012.09.014_bib0030","doi-asserted-by":"crossref","first-page":"822","DOI":"10.2337\/diacare.21.5.822","article-title":"Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers: a phase III randomized placebo-controlled double-blind study","volume":"21","author":"Wieman","year":"1998","journal-title":"Diabetes Care"},{"issue":"2","key":"10.1016\/j.semcdb.2012.09.014_bib0035","doi-asserted-by":"crossref","first-page":"290","DOI":"10.2337\/diacare.24.2.290","article-title":"Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial","volume":"24","author":"Veves","year":"2001","journal-title":"Diabetes Care"},{"issue":"6","key":"10.1016\/j.semcdb.2012.09.014_bib0040","doi-asserted-by":"crossref","first-page":"1701","DOI":"10.2337\/diacare.26.6.1701","article-title":"The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers","volume":"26","author":"Marston","year":"2003","journal-title":"Diabetes Care"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0045","doi-asserted-by":"crossref","DOI":"10.1111\/j.1742-481X.2011.00907.x","article-title":"Letter: designing clinical trials to bring wound products to market","author":"Vivas","year":"2011","journal-title":"International Wound Journal"},{"issue":"4","key":"10.1016\/j.semcdb.2012.09.014_bib0050","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1046\/j.1524-475X.2001.00258.x","article-title":"Guidance for industry: chronic cutaneous ulcer and burn wounds \u2013 developing products for treatment","volume":"9","author":"FDA Wound Healing Clinical Focus Group","year":"2001","journal-title":"Wound Repair and Regeneration"},{"issue":"6","key":"10.1016\/j.semcdb.2012.09.014_bib0055","doi-asserted-by":"crossref","first-page":"237","DOI":"10.12968\/jowc.2010.19.6.48471","article-title":"Outcomes in controlled and comparative studies on non-healing wounds: recommendations to improve the quality of evidence in wound management","volume":"19","author":"Gottrup","year":"2010","journal-title":"Journal of Wound Care"},{"issue":"6","key":"10.1016\/j.semcdb.2012.09.014_bib0060","doi-asserted-by":"crossref","first-page":"1879","DOI":"10.2337\/diacare.26.6.1879","article-title":"Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial","volume":"26","author":"Sheehan","year":"2003","journal-title":"Diabetes Care"},{"issue":"5","key":"10.1016\/j.semcdb.2012.09.014_bib0065","doi-asserted-by":"crossref","first-page":"758","DOI":"10.1016\/j.jaad.2008.07.018","article-title":"A gene signature of nonhealing venous ulcers: potential diagnostic markers","volume":"59","author":"Charles","year":"2008","journal-title":"Journal of the American Academy Dermatology"},{"issue":"1","key":"10.1016\/j.semcdb.2012.09.014_bib0070","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/S0002-9440(10)62953-7","article-title":"Molecular pathogenesis of chronic wounds: the role of Beta-catenin and c-myc in the inhibition of epithelialization and wound healing","volume":"167","author":"Stojadinovic","year":"2005","journal-title":"American Journal of Pathology"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0075","unstructured":"O\u2019Connor NR. Diabetes mellitus (type 2). Essential evidence plus. http:\/\/www.essentialevidenceplus.com\/content\/eee\/127?section=6. Updated April 30, 2012 [accessed 20.06.12]."},{"issue":"8","key":"10.1016\/j.semcdb.2012.09.014_bib0080","doi-asserted-by":"crossref","first-page":"1354","DOI":"10.2337\/diacare.22.8.1354","article-title":"Consensus development conference on diabetic foot wound care: 7\u20138 April 1999, Boston, MA. American Diabetes Association","volume":"22","year":"1999","journal-title":"Diabetes Care"},{"issue":"8","key":"10.1016\/j.semcdb.2012.09.014_bib0085","doi-asserted-by":"crossref","first-page":"818","DOI":"10.2337\/diacare.19.8.818","article-title":"Reducing dynamic foot pressures in high-risk diabetic subjects with foot ulcerations: a comparison of treatments","volume":"19","author":"Lavery","year":"1996","journal-title":"Diabetes Care"},{"issue":"6","key":"10.1016\/j.semcdb.2012.09.014_bib0090","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.2337\/diacare.24.6.1019","article-title":"Off-loading the diabetic foot wound: a randomized clinical trial","volume":"24","author":"Armstrong","year":"2001","journal-title":"Diabetes Care"},{"issue":"6","key":"10.1016\/j.semcdb.2012.09.014_bib0095","doi-asserted-by":"crossref","first-page":"384","DOI":"10.2337\/diacare.12.6.384","article-title":"Total contact casting in treatment of diabetic plantar ulcers: controlled clinical trial","volume":"12","author":"Mueller","year":"1989","journal-title":"Diabetes Care"},{"issue":"9","key":"10.1016\/j.semcdb.2012.09.014_bib0100","doi-asserted-by":"crossref","first-page":"2595","DOI":"10.2337\/diacare.26.9.2595","article-title":"Activity patterns of patients with diabetic foot ulceration: patients with active ulceration may not adhere to a standard pressure off-loading regimen","volume":"26","author":"Armstrong","year":"2003","journal-title":"Diabetes Care"},{"issue":"7","key":"10.1016\/j.semcdb.2012.09.014_bib0105","doi-asserted-by":"crossref","first-page":"405","DOI":"10.7547\/87507315-92-7-405","article-title":"Technique for fabrication of an \u201cinstant\u201d total contact cast for treatment of neuropathic diabetic foot ulcers","volume":"92","author":"Armstrong","year":"2002","journal-title":"Journal of the American Podiatric Medical Association"},{"issue":"3","key":"10.1016\/j.semcdb.2012.09.014_bib0110","doi-asserted-by":"crossref","first-page":"551","DOI":"10.2337\/diacare.28.3.551","article-title":"Evaluation of removable and irremovable cast walkers in the healing of diabetic foot wounds: a randomized controlled trial","volume":"28","author":"Armstrong","year":"2005","journal-title":"Diabetes Care"},{"issue":"1","key":"10.1016\/j.semcdb.2012.09.014_bib0115","first-page":"61","article-title":"Effect of extensive debridement and treatment on the healing of diabetic foot ulcers","volume":"183","author":"Steed","year":"1996","journal-title":"Journal of American College of Surgeon"},{"issue":"6","key":"10.1016\/j.semcdb.2012.09.014_bib0120","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1016\/j.jamcollsurg.2008.09.018","article-title":"Operative debridement of diabetic foot ulcers","volume":"207","author":"Golinko","year":"2008","journal-title":"Journal of American College Surgery"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0125","series-title":"Compression therapy in practice","author":"Moffatt","year":"2007"},{"issue":"9","key":"10.1016\/j.semcdb.2012.09.014_bib0130","doi-asserted-by":"crossref","first-page":"1","DOI":"10.3310\/hta5090","article-title":"Systematic reviews of wound care management: (5) beds; (6) compression; (7): laser therapy, therapeutic ultrasound, electrotherapy and electromagnetic therapy","volume":"5","author":"Cullum","year":"2001","journal-title":"Health Technology Assessment"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0135","unstructured":"Marston W, Vowden K. Compression therapy: a guide to safe practice. In: European Wound Management Association (EWMA). Position Document. Understanding Compression Therapy. London: MEP Ltd, 2003; 11\u20136. Available from URL: http:\/\/www.ewma.org\/."},{"key":"10.1016\/j.semcdb.2012.09.014_bib0140","first-page":"130","article-title":"Compression therapy of venous ulcers","volume":"Vol. 27","author":"Partsch","year":"1999"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0145","series-title":"Leg ulcer management","author":"Moffatt","year":"2007"},{"issue":"3","key":"10.1016\/j.semcdb.2012.09.014_bib0150","doi-asserted-by":"crossref","first-page":"274","DOI":"10.1111\/j.1365-2648.2006.03816.x","article-title":"Class-3c compression bandaging for venous ulcers: comparison of spiral and figure-of-eight techniques","volume":"54","author":"Coull","year":"2006","journal-title":"Journal of Advanced Nursing"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0155","first-page":"1","article-title":"An evaluation of a new type of compression bandaging system","author":"Thomas","year":"2003","journal-title":"World Wide Wounds"},{"issue":"6610","key":"10.1016\/j.semcdb.2012.09.014_bib0160","doi-asserted-by":"crossref","first-page":"1382","DOI":"10.1136\/bmj.295.6610.1382","article-title":"Hazards of compression treatment of the leg: an estimate from Scottish surgeons","volume":"295","author":"Callam","year":"1987","journal-title":"British Medical Journal (Clinical Research Edition)"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0165","series-title":"Presented at AVF","article-title":"Variability of interface pressure exerted by compression bandages and standard size compression stockings","author":"Partsch","year":"2008"},{"key":"10.1016\/j.semcdb.2012.09.014_bib0170","doi-asserted-by":"crossref","first-page":"b1344","DOI":"10.1136\/bmj.b1344","article-title":"Four layer bandage compared with short stretch bandage for venous leg ulcers: systematic review and meta-analysis of randomised controlled trials with data from individual patients","volume":"338","author":"O\u2019Meara","year":"2009","journal-title":"British Medical Journal"},{"issue":"1","key":"10.1016\/j.semcdb.2012.09.014_bib0175","doi-asserted-by":"crossref","first-page":"179","DOI":"10.1097\/PRS.0b013e3182362a53","article-title":"Factors associated with poor healing and recurrence of venous ulceration","volume":"129","author":"Labropoulos","year":"2012","journal-title":"Plastic and Reconstructive Surgery"},{"issue":"2","key":"10.1016\/j.semcdb.2012.09.014_bib0180","doi-asserted-by":"crossref","first-page":"131","DOI":"10.1111\/j.1067-1927.2005.130203.x","article-title":"Effect of sharp debridement using curette on recalcitrant nonhealing venous leg ulcers: a concurrently controlled, prospective cohort study","volume":"13","author":"Williams","year":"2005","journal-title":"Wound Repair and Regeneration"},{"issue":"3","key":"10.1016\/j.semcdb.2012.09.014_bib0185","doi-asserted-by":"crossref","first-page":"306","DOI":"10.1111\/j.1524-475X.2009.00485.x","article-title":"Serial surgical debridement: a retrospective study on clinical outcomes in chronic lower extremity wounds","volume":"17","author":"Cardinal","year":"2009","journal-title":"Wound Repair and Regeneration"},{"issue":"5","key":"10.1016\/j.semcdb.2012.09.014_bib0190","doi-asserted-by":"crossref","first-page":"837","DOI":"10.1016\/j.jvs.2005.01.042","article-title":"Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: A randomized clinical trial","volume":"41","author":"Mostow","year":"2005","journal-title":"Journal of Vascular Surgery"},{"issue":"8","key":"10.1016\/j.semcdb.2012.09.014_bib0195","doi-asserted-by":"crossref","first-page":"749","DOI":"10.1111\/j.1464-5491.1992.tb01885.x","article-title":"Foot infections in diabetes are rarely due to a single microorganism","volume":"9","author":"Hunt","year":"1992","journal-title":"Diabetic Medicine"},{"issue":"6","key":"10.1016\/j.semcdb.2012.09.014_bib0200","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1111\/j.1524-475X.2006.00174.x","article-title":"Guidelines for the treatment of venous ulcers","volume":"14","author":"Robson","year":"2006","journal-title":"Wound Repair and Regeneration"},{"issue":"3","key":"10.1016\/j.semcdb.2012.09.014_bib0205","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1046\/j.1524-475X.1994.20304.x","article-title":"Regulatory concerns in the development of topical recombinant ophthalmic and cutaneous wound healing biologics","volume":"2","author":"Stromberg","year":"1994","journal-title":"Wound Repair and Regeneration"},{"issue":"2","key":"10.1016\/j.semcdb.2012.09.014_bib0210","doi-asserted-by":"crossref","first-page":"90","DOI":"10.1046\/j.1524-475X.1999.00090.x","article-title":"Original articles: ease of wound closure as an endpoint of treatment efficacy","volume":"7","author":"Robson","year":"1999","journal-title":"Wound Repair and Regeneration"}],"container-title":["Seminars in Cell & Developmental Biology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1084952112001796?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1084952112001796?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2018,11,20]],"date-time":"2018-11-20T07:52:16Z","timestamp":1542700336000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1084952112001796"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,12]]},"references-count":42,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2012,12]]}},"alternative-id":["S1084952112001796"],"URL":"https:\/\/doi.org\/10.1016\/j.semcdb.2012.09.014","relation":{},"ISSN":["1084-9521"],"issn-type":[{"value":"1084-9521","type":"print"}],"subject":[],"published":{"date-parts":[[2012,12]]}}}