Inflammatory Biomarkers to Diagnose and Monitor Diabetic Foot Osteomyelitis

NCT04025853 | Completed

• 1 other identifier: 042015-048
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with foot infections.

You may qualify if:

• Patients of the investigators.
• Male and female
• ages 18-89
• moderate diabetic foot infections (according to IDSA criteria) and non-diabetic foot infections who presented for treatment between January 1, 2010 and December 31, 2015. •positive case of osteomyelitis as bone with positive bacterial cultures or histologic finding of acute or chronic osteomyelitis.
• The investigators will only enroll patients who have an initial baseline CRP or ESR within 72 hours of admission, before any surgical procedures.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Related Publications (4)

• 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.

  PMID: 22100977 BACKGROUND

• 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.

  PMID: 23468086 BACKGROUND

• 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.

  PMID: 19940225 BACKGROUND

• 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.

  PMID: 16799390 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Lawrence Lavery, DPM

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Plastic Surgery; Principal Investigator

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: July 19, 2019
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)