NCT04025853|Completed
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Sponsor study identifier
observational
455
1 country
1
Study Start
June 2015
Actual (reported)Primary Completion
March 2018
Actual (reported)Study Completion
March 2018
Actual (reported)The investigators plan to do a retrospective chart review of 500 patients admitted to the hospital between January 1, 2010 and December 31, 2015 with diabetic foot infections. The investigators will define a positive case of osteomyelitis as bone with positive bacterial cultures or histologic finding of acute or chronic osteomyelitis. Levels of inflammatory biomarkers (CRP, ESR) will be collected from the charts from the first time of diagnosis. Because wound healing, biomarker levels and resolution of infection are clearly affected by other factors such as demographics, medical/surgical history, social history, medications, laboratory results, peripheral arterial disease, wound severity, and treatment factors such as type of antibiotics, off-loading, debridement and vascular surgery interventions these will also be collected. The investigators will collect this clinical data for both cohorts.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2015
Actual (reported)March 2018
Actual (reported)March 2018
Actual (reported)May 17, 2019
Actual (reported)July 19, 2019
Actual (reported)Evaluate the effectiveness of biomarkers to diagnose diabetic foot osteomyelitis using bone culture and histopathology as the "gold standard" to establish the diagnosis.
To correlate the level of white blood cell count, c-reactive protein and erythrocyte sedimentation rate with the results of bone culture and histopathology as the "gold standard" to establish the diagnosis.
2 years
Evaluate the effectiveness of biomarkers to differentiate osteomyelitis from deep soft tissue infections in patients with diabetic foot ulcers.
To correlate the accuracy of white blood cell count, c-reactive protein and erythrocyte sedimentation rate to differentiate osteomyelitis by observing the results of bone culture and histopathology as the "gold standard" to establish the diagnosis.
2 years
Patients with foot infections.
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Guariguata L, Whiting D, Weil C, Unwin N. The International Diabetes Federation diabetes atlas methodology for estimating global and national prevalence of diabetes in adults. Diabetes Res Clin Pract. 2011 Dec;94(3):322-32. doi: 10.1016/j.diabres.2011.10.040. Epub 2011 Nov 17.
American Diabetes Association. Economic costs of diabetes in the U.S. in 2012. Diabetes Care. 2013 Apr;36(4):1033-46. doi: 10.2337/dc12-2625. Epub 2013 Mar 6.
Lawrence Lavery, DPM
University of Texas Southwestern Medical Center
455 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2019
First Posted
July 19, 2019
Study Start
June 2015
Actual (reported)Treatment of Foot and Leg Ulcers Using a Laser
Contact the study team to confirm eligibility.
Huang ES, Basu A, O'Grady M, Capretta JC. Projecting the future diabetes population size and related costs for the U.S. Diabetes Care. 2009 Dec;32(12):2225-9. doi: 10.2337/dc09-0459.
Lipsky BA, Berendt AR, Deery HG, Embil JM, Joseph WS, Karchmer AW, LeFrock JL, Lew DP, Mader JT, Norden C, Tan JS; Infectious Diseases Society of America. Diagnosis and treatment of diabetic foot infections. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):212S-238S. doi: 10.1097/01.prs.0000222737.09322.77.
Primary Completion
March 2018
Actual (reported)Study Completion
March 2018
Actual (reported)Last Updated
July 24, 2023
Record last verified: 2023-07
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