{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T16:08:43Z","timestamp":1791389323955,"version":"4.3.3"},"reference-count":42,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2025,2,19]],"date-time":"2025-02-19T00:00:00Z","timestamp":1739923200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Diabetic foot osteomyelitis (DFO) is associated with a considerably high risk of incident major amputations, disability and mortality. To assess the effects of\u00a0a local antibiotic delivery system on the incidence of post\u2010surgical infective complications in patients with DFO.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This is a double\u2010blind, placebo\u2010controlled, parallel series, randomized controlled trial (RCT) aimed at verifying the efficacy and safety of a local calcium\u2010sulphate bio\u2010absorbable antibiotic delivery (either with tobramycin or vancomycin) in patients with DFO treated with surgical procedures. The trial enrolled adult patients with diabetes and Texas 3 grade ulcers complicated by osteomyelitis and accompanied by deep tissues infection. The primary end\u2010point was the percentage of infective complications (composite end\u2010point of dehiscence, infection, DFO recurrence and new DFO in adjacent sites) at 12\u2009weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The study was prematurely terminated after the completion of the first 20 cases, because of the significant superiority of the active treatment arm. After 12\u2009weeks of treatment, five of 20 wounds (25%) achieved the primary composite end\u2010point. All post\u2010surgical infective complications occurred in the placebo group, with a significant between\u2010group difference (unadjusted\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.010). No between\u2010group differences in overall costs were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This is the first RCT in patients with DFO showing that the use of antibiotic\u2010impregnated calcium\u2010sulphate granules is economically sustainable and has the potential of improving the prognosis of DFO.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.16254","type":"journal-article","created":{"date-parts":[[2025,2,19]],"date-time":"2025-02-19T23:48:38Z","timestamp":1740008918000},"page":"2552-2560","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Efficacy and safety of a\n                    <scp>bio<\/scp>\n                    \u2010absorbable antibiotic delivery in calcium sulphate granules for the treatment of osteomyelitis in patients with diabetic foot: A randomized, double blinded, controlled clinical study The\n                    <scp>BIG<\/scp>\n                    D\u2010\n                    <scp>FOOT<\/scp>\n                    study"],"prefix":"10.1111","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9349-828X","authenticated-orcid":false,"given":"Matteo","family":"Monami","sequence":"first","affiliation":[{"name":"Diabetology, Careggi Hospital  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Bordoni","sequence":"additional","affiliation":[{"name":"University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benedetta","family":"Ragghianti","sequence":"additional","affiliation":[{"name":"Diabetology, Careggi Hospital  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6695-3213","authenticated-orcid":false,"given":"Giovanni Antonio","family":"Silverii","sequence":"additional","affiliation":[{"name":"University of Florence  Florence Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9759-9408","authenticated-orcid":false,"given":"Edoardo","family":"Mannucci","sequence":"additional","affiliation":[{"name":"University of Florence  Florence 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