Immunonutrition for Diabetic Foot Ulcers
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (107 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-03-20, after 2023-02-08 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-03-20. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: hemodialysisstageenrollmentcarekidney disease
Phrases that lowered it: effectevaluate thediabetesclinicaldiabetic -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Maximum age: 99 (lowers risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 6.7% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 65.7% (lowers risk) · Drug's FDA history
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Phase: 2/3 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports before start: 361151 (lowers risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 27448 (lowers risk) · Drug's FDA history
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 99 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 361151 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 27448 (typical: 412.5)
- Drug's FAERS reports marked serious
- 65.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 6.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, metabolic, dermatology, endocrine
- Drugs matched to FDA substances
- arginine, ascorbic acid, fatty acids, omega3 acid ethyl esters, omega3 fatty acids
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients NCT06117436 · started 2023 · scored riskier than 22% of active trials completed
- Topical Erythropoietin Hydrogel Formulation for Diabetic Foot Ulcers NCT02361931 · started 2016 · scored riskier than 34% of active trials completed
- Beta Adrenergic Antagonist for the Healing of Chronic DFU NCT03282981 · started 2018 · scored riskier than 50% of active trials completed
- Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers NCT05608187 · started 2022 · scored riskier than 39% of active trials terminated
- Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers NCT02036528 · started 2014 · scored riskier than 34% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.