Evaluation of the clinical utility, efficacy and safety of a novel medical device for the treatment of foot ulcers: Rationale and design of the carbothera trial
Bibliographic record
Abstract
BACKGROUND: Foot ulceration usually precedes more serious foot complications such as infection, gangrene or amputation. The risk of developing foot ulcers has been estimated to be higher in individuals with peripheral arterial disease, diabetes and kidney disease. OBJECTIVE: To evaluate the healing potential of CO2-enriched water in patients with foot ulceration. METHODS: This is a multi-centered; placebo controlled and randomized clinical trial. Patients will have at least 1 distal extremity ulcer and will be randomized to receive a treatment with bath therapy at 37oC containing either 1,000-1200 ppm CO2-enriched tap water (the intervention), or non- carbonated tap water (the control group). The treatment will be carried out 3 times/week for 15 minutes per session for 4 months for a total of 48 treatments. At baseline and at the end of every treatment month, wound assessment, measurement of limb oxygenation, ankle brachial pressures as well as McGill pain questionnaire will be carried out. Blood will also be collected at baseline and at the end of every month of the treatment period (for a total of 5 collections) for the measurement of different biomarkers. BASELINE DATA: At baseline all 14 participants have at least one distal extremity ulcer and 93% (13/14) are diabetic. Although 6 of the participan`ts have peripheral arterial disease (left and/or right limb) as evidenced by an ankle brachial index (ABI) <0.9, another 5 exhibited non-compressible ankle arteries and 3 participants with left and right ABI of ≥ 0.9. Mean age of participants is 60.2 ± 1.7 and 64% (9/14) of the participants are undergoing hemodialysis for ESRD and 29% (4/14) are below knee amputees. CONCLUSIONS: The proposed clinical study will evaluatve the therapeutic potential, safety and efficacy of CO2 enriched water (produced by the Carbothera device) on treating foot ulcers.
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How this classification was reachedexpand
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 | 0.011 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, 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".