Diabetic foot ulcer treatment with focused shockwave therapy: two multicentre, prospective, controlled, double-blinded, randomised phase III clinical trials
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Bibliographic record
Abstract
OBJECTIVE: To investigate the efficacy of focused extracorporeal shockwave therapy (ESWT) as an adjunctive treatment for neuropathic diabetic foot ulcers (DFU) (1A or 2A on the University of Texas grading scheme), compared with sham treatment. METHOD: We performed two multicentre, randomised, sham-controlled, double-blinded, phase III clinical trials using focused ESWT compared with sham examining DFUs that did not reduce in volume by ≥50% over 2 weeks' standard treatment immediately prior to randomisation. Patients were enrolled into the trials and randomised for either standard care and focused ESWT (pulsed acoustic cellular expression. dermaPACE System, SANUWAVE Health Inc.) active therapy, or standard care and sham therapy. Both active and sham therapy were administered four times in 2 weeks in study 1 and a maximum of eight times over 12 weeks in study 2. Standard care continued in both studies throughout the 12-week treatment phase. The proportion of DFUs that closed completely by 12, 20 and 24 weeks was measured. RESULTS: The two studies evaluated 336 patients; 172 patients treated with active therapy and 164 managed with a sham device. The demographic characteristics of patients in the two arms of both studies were balanced and statistical comparison of the two studies justified pooling datasets for analysis. Statistically significantly more DFU healed at 20 (35.5% versus 24.4%; p=0.027) and 24 weeks (37.8% versus 26.2%; p=0.023) in the active treatment arm compared with the sham-controlled arm. At 12 weeks the active therapy arm trended to significance (22.7% versus 18.3%). CONCLUSION: The outcome of these two trials suggests that ESWT is an effective therapeutic modality in combination with standard care for neuropathic DFU that do not respond to standard care alone.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 it