Peptide Library

Human study PLS-00155

Thymosin beta-4 and venous ulcers: clinical remarks on a European prospective, randomized study on safety, tolerability, and enhancement on healing.

Randomized controlled trial · 21 participants enrolled

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

  • Thymosin beta-4 and venous ulcers: clinical remarks on a European prospective, randomized study on safety, tolerability, and enhancement on healing.primary · Annals of the New York Academy of Sciences · 2007-05-10 · PMID 17495250 · DOI

Design and participants

Design
Randomized controlled trial
Population
Patients with venous ulcers enrolled sequentially into three dose-escalation groups. At the time of the report, 21 patients had been enrolled in the first (lowest-dose) group.
Conditions
Venous ulcer
Setting
Multicenter: 10 sites, 5 in Italy and 5 in Poland (Italy, Poland)
Planned enrollment (registry)
72
Enrolled
21
Randomized
Not reported
Completed follow-up
Not reported

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

  • Thymosin beta-4 topical (intervention) · thymosin-beta-4 · Topical thymosin beta-4 at escalating levels across three sequential groups, with debridement as needed and class 2 compression stockings · topical · 84 days of treatment plus 14 days follow-up · Not reported assigned
  • Placebo (comparator) · Placebo, randomized 3:1 (thymosin beta-4 to placebo) within each group, with standard ulcer care and compression · placebo · topical · 84 days of treatment plus 14 days follow-up · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Incidence of complete healing of index ulcer

unclear outcome · patient-important · Day 84 · Percentage of patients with complete closure of the index ulcer

  • No results reported.

Time to complete healing

unclear outcome · patient-important · Through day 84 · Mean time to complete healing

  • No results reported.

Ulcer area

unclear outcome · surrogate · Weekly visits / not stated · Digital planimetry and photographic analysis

  • No results reported.

Safety and tolerability (adverse events, dose-limiting adverse events, laboratory tests)

unclear outcome · safety · Weekly through end of treatment and follow-up · Adverse event review; weekly clinical chemistry, hematology, coagulation and urinalysis

  • No results reported.

Plasma thymosin beta-4 levels

unclear outcome · surrogate · Day 0 and end of treatment · Blood samples

  • No results reported.

Adverse events

None reported. That is not evidence of safety.

Monitoring: Weekly visits with blood sampling for clinical chemistry, hematology, coagulation and urinalysis. Safety data are reviewed for dose-limiting adverse events before each new dose group is enrolled.

The authors concluded (paraphrased): The study was ongoing. The authors suggest that patient compliance and motivated, well-trained teams are the most important factors for successfully conducting the study.

Peptide Library’s assessment

An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.

Limitations

  • selective reporting: The report describes an ongoing trial and presents no efficacy or safety results for any outcome.
  • abstract only: Only the abstract is available, so methods, randomization details and conflicts cannot be assessed.
  • small or imprecise: Only 21 patients had been enrolled at the time of the report, and the planned total was 72.
  • funding or conflicts: Funding sources and author conflicts of interest are not reported in the record.
  • other: The study was ongoing at the time of publication, so no efficacy or safety results exist to appraise.

No risk-of-bias assessment has been published for this study’s results.

Claims this study informs

Where each value comes from

  • arms: PMID 17495250, abstract (sentences 3, 6 and 9) · extracted by AI (automated, not verified by a person) · abstract only
  • author_conclusion: PMID 17495250, abstract (sentence 13) · extracted by AI (automated, not verified by a person) · abstract only
  • design: PMID 17495250, abstract (sentences 1-4) · extracted by AI (automated, not verified by a person) · abstract only
  • limitations: PMID 17495250, abstract (sentence 12) · extracted by AI (automated, not verified by a person) · abstract only
  • outcomes: PMID 17495250, abstract (sentences 7, 8, 10 and 11) · extracted by AI (automated, not verified by a person) · abstract only
  • participants: PMID 17495250, abstract (sentences 3, 6 and 12) · extracted by AI (automated, not verified by a person) · abstract only
  • population: PMID 17495250, abstract (sentences 1-2 and 12) · extracted by AI (automated, not verified by a person) · abstract only

  • Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).