Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-11-01. 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.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: randomizationto screeningpriordefinedvisit
  Phrases that lowered it: evaluate theto evaluateulcerindexefficacy
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
• Phase: 2 (raises risk) · Design
• Design: parallel (raises risk) · Design
• Has a data monitoring committee: Yes (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Minimum age: 18 (raises risk) · Who can join
• Disease area, cancer: No (lowers risk) · Disease area
• Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Number of arms: 2 (raises risk) · Design
• Collaborators: 1 (raises risk) · Design
• Disease area, dermatology: Yes (raises risk) · Disease area
• Blinding: none (raises risk) · Design
• Sponsor's past trials: 0 (lowers risk) · Sponsor's track record
• Disease area, cardiovascular: Yes (raises risk) · Disease area

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.

• Nu-3 Topical Gel for Treatment of Diabetic Foot Ulcer NCT05276401 · started 2022 · scored riskier than 10% of active trials terminated
• Evaluate the Safety and Efficacy of ON101 Cream for the Treatment of Chronic Diabetic Foot Ulcers NCT04962139 · started 2021 · scored riskier than 26% of active trials terminated
• Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs NCT05372809 · started 2022 · scored riskier than 80% of active trials terminated
• Phase 3 Study Evaluating Efficacy and Safety of DSC127 Compared With Vehicle and With Standard-of-care in Diabetic Foot Ulcers NCT01849965 · started 2013 · scored riskier than 60% of active trials terminated
• Treatment of Diabetic Foot Ulcers With AUP1602-C NCT04281992 · started 2020 · scored riskier than 56% of active trials completed

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.