Bone Biopsy not Superior to Ulcer Bed Biopsy–guided Antibacterial Therapy on Remission of Diabetic Foot Osteomyelitis: A Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Percutaneous bone biopsy is the reference standard for guiding antibiotic therapy in diabetic foot osteomyelitis (DFO). However, ulcer bed biopsies are commonly used in practice. This study aimed to compare 12-month outcomes of patients with conservatively treated DFO whose antibiotic regimens were based on cultures of either percutaneous bone or ulcer bed biopsy. METHODS: We conducted a multicenter, double-blind randomized clinical trial in 84 adult participants with DFO. All underwent a percutaneous bone biopsy and an ulcer bed biopsy. Participants were randomly allocated to antibiotic treatment based on either bone biopsy cultures or ulcer bed biopsy cultures. The primary outcome, DFO remission, was assessed at 12 months using both intention-to-treat and per-protocol analyses with generalized linear models. RESULTS: The remission rate in the bone biopsy group was 31.4% (95% confidence interval [CI], 18.1-48.7) and 39.4% (95% CI, 24.2-57.0) in the ulcer bed biopsy group. The relative risk of not achieving remission at 12 months in the bone biopsy group was 1.13 (95% CI, 0.80-1.60) in the intention-to-treat analyses and ranged from 1.12 to 1.18 in the per-protocol analyses. Antibiotics targeting bacteria identified in the unblinded sample were effective against all bacteria cultured from the blinded sample in 85.9% of cases (n = 61). CONCLUSIONS: This study found no evidence to recommend bone biopsies prior to the start of antibiotics in patients with DFO. In most cases, the antibiotics targeted bacteria in both samples, possibly contributing to the equivalence of the results in outcomes in both groups. CLINICAL TRIALS REGISTRATION: Netherlands Trial Register NL 7582.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".