Cardiovascular

Clinical Diagnosis Versus Plain Radiography for Diabetic Foot Osteomyelitis: A Prospective Study of Diagnostic Agreement in a Resource-Limited Settings.

TL;DR

In 166 patients with deep diabetic foot ulcers, a composite clinical diagnosis (clinical assessment plus probe-to-bone test) showed substantial agreement with plain radiography for diabetic foot osteomyelitis, and may serve as a practical adjunct where imaging is unavailable, but it is not a definitive diagnostic test without an independent reference standard.

Key Findings

A composite clinical approach identified osteomyelitis in 117 of 166 patients with deep foot ulcers and excluded it in 49.

  • Prospective cohort conducted from December 2021 to January 2025 among patients with suspected DFO.
  • Participants underwent clinical evaluation, risk factor assessment, ulcer history, SINBAD classification, probe-to-bone testing and plain radiography.
  • The composite diagnosis combined clinical assessment with the probe-to-bone test.

Plain radiography was positive in 96 of the 117 composite-positive cases, leaving 21 discordant cases, while all 49 composite-negative cases were radiographically negative.

  • 21 composite-positive patients had negative radiographs.
  • No composite-negative patient had a positive radiograph, which yields the 100% sensitivity relative to radiography.

Compared with plain radiography, the composite clinical approach had 100% sensitivity, 70% specificity and 87.3% overall agreement.

  • Performance measures represent comparative diagnostic agreement with radiography, not absolute diagnostic accuracy.
  • No bone biopsy reference standard was available in this low-resource setting.

Sensitivity stayed at 100% across ulcer categories, while specificity was higher in SINBAD-5 than SINBAD-4 ulcers.

  • Specificity increased significantly from 63.8% in SINBAD-4 ulcers to 77.8% in SINBAD-5 ulcers.
  • Overall agreement improved from 86.1% to 89.7%.

The authors conclude the composite clinical diagnosis shows substantial agreement with radiography and may be a practical adjunct in resource-limited settings, but is not a definitive test.

  • Most useful where imaging is unavailable or difficult to interpret.
  • Lack of an independent reference standard (bone biopsy) means it should not be considered definitive.

What This Means

Diabetic foot osteomyelitis is a bone infection that can complicate deep foot ulcers in people with diabetes. In places with limited access to imaging, doctors may need to rely on examination and a bedside probe-to-bone test. This study followed 166 patients with deep foot ulcers and compared a combined clinical approach (examination plus probe-to-bone testing) with plain X-rays. The clinical approach flagged 117 patients as having bone infection, and X-rays agreed in 96 of them. All 49 patients cleared by the clinical approach also had negative X-rays. Overall, the two methods agreed in about 87% of patients. The clinical approach missed no X-ray-positive cases, but it labelled some patients as positive whose X-rays were negative, and this was more common in less severe (SINBAD-4) ulcers than in more severe (SINBAD-5) ones. This research suggests that a combined clinical approach could be a useful supporting tool where imaging is hard to get or interpret. However, the comparison was against X-rays rather than bone biopsy, the more definitive test, so the findings show agreement rather than true accuracy. The authors caution that it should not be treated as a definitive diagnostic test.

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Citation

Abbas Z, Gangji R, Naemi R. (2026). Clinical Diagnosis Versus Plain Radiography for Diabetic Foot Osteomyelitis: A Prospective Study of Diagnostic Agreement in a Resource-Limited Settings.. International wound journal. https://doi.org/10.1111/iwj.71085