Human study PLS-00156

The effect of thymosin treatment of venous ulcers.

Randomized controlled trial · 73 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.

The effect of thymosin treatment of venous ulcers.primary · Annals of the New York Academy of Sciences · 2010-04-01 · PMID 20536470 · DOI

Design and participants

Design: Randomized controlled trial
Population: Patients with venous stasis ulcers of the lower limbs
Conditions: Venous stasis ulcer (varicose ulcer)
Setting: Multicenter study at eight European sites (five in Italy, three in Poland) (Italy, Poland)
Planned enrollment (registry): Not reported
Enrolled: 73
Randomized: 73
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 (dose-escalation groups) (intervention) · thymosin-beta-4 · Synthetic copy of the naturally occurring 43-amino-acid thymosin beta 4 peptide, applied topically at escalating doses. Per-dose group sizes are not reported in the abstract. · topical · Not reported assigned
Placebo (comparator) · Topical placebo · placebo · topical · Not reported assigned

What the authors reported

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

Safety and tolerability

unclear outcome · safety · Safety profile of administered doses, compared with placebo

Thymosin beta 4 topical (dose-escalation groups) vs Placebo: narrative — Safety profile of all Tβ4 doses deemed acceptable and comparable to placebo

Complete wound healing

unclear outcome · patient-important · Within 3 months · Complete healing of the venous ulcer

Thymosin beta 4 topical (dose-escalation groups) vs Placebo: narrative — Complete healing within 3 months in about a quarter of patients, especially those with small-to-moderate or mild-to-moderate wounds

Rate of wound healing

unclear outcome · patient-important · Acceleration of wound healing

Thymosin beta 4 topical (dose-escalation groups) vs Placebo: narrative — One Tβ4 dose may have the potential to accelerate wound healing

Adverse events

None reported. That is not evidence of safety.

Monitoring: Safety and tolerability were assessed. The abstract does not describe the monitoring methods.

The authors concluded (paraphrased): All Tβ4 doses had an acceptable safety profile comparable to placebo. One dose may accelerate venous ulcer healing, and about a quarter of patients achieved complete healing within 3 months, especially those with smaller or less severe wounds.

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

abstract only: Only the abstract is available. Methods, per-arm numbers and quantitative results are not reported.
small or imprecise: 73 patients were randomized across several dose-escalation groups and placebo, so each group was small.
selective reporting: Efficacy claims rest on a single dose and on subgroups with smaller or less severe wounds, with no statistics reported.
other: Phase 2 dose-escalation design with hedged efficacy language ('may have the potential'); the findings are exploratory.
funding or conflicts: Funding and conflicts of interest are not stated in the record.

Safety and tolerability: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	The abstract states patients were randomized but gives no detail on sequence generation or allocation concealment.
Deviations from intended interventions	Some concerns	Described as double-blind and placebo-controlled, but adherence and deviations are not reported in the abstract.
Missing outcome data	High risk of bias	The abstract does not report the number completing or analyzed in each arm.
Measurement of the outcome	Some concerns	Double-blinding supports assessment, but the methods for collecting adverse events are not described.
Selection of the reported result	High risk of bias	Safety is summarized only as acceptable and comparable to placebo with no counts or data.

Randomized double-blind design, but the abstract-only report lacks detail on allocation, missing data and event counts.

Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Complete wound healing: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization is stated, but its method and concealment are not described in the abstract.
Deviations from intended interventions	Some concerns	Double-blind placebo control is stated; deviations from the intended interventions are not reported.
Missing outcome data	High risk of bias	No completion or analysis numbers are given in the abstract for any arm.
Measurement of the outcome	Some concerns	Blinding is stated, but how complete healing was assessed is not described.
Selection of the reported result	High risk of bias	The efficacy claim highlights one dose and favourable wound subgroups without a reported prespecified comparison or statistics.

Selective emphasis on one dose and on subgroups, with no reported comparative statistics, puts the reported efficacy result at high risk.

Rate of wound healing: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization is stated, but its method and concealment are not described in the abstract.
Deviations from intended interventions	Some concerns	Double-blind placebo control is stated; deviations from the intended interventions are not reported.
Missing outcome data	High risk of bias	No completion or analysis numbers are given in the abstract for any arm.
Measurement of the outcome	Some concerns	How the healing rate was measured is not described in the abstract.
Selection of the reported result	High risk of bias	Only a hedged claim that one dose 'may' accelerate healing is reported, suggesting selection among doses.

Hedged single-dose efficacy claim without reported statistics indicates high risk of selective reporting.

Claims this study informs

Improves dry eye signs and symptoms: not eligible (wrong population) for “Ocular discomfort and corneal staining”
Is safe for human administration: eligible for “Adverse events, serious adverse events and discontinuations”, direct evidence

Insufficient information to assess Adverse events, serious adverse events and discontinuations

Where each value comes from

arms: PMID 20536470, abstract (sentences 3-4) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 20536470, abstract (sentences 5-6) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 20536470, abstract (sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 20536470, abstract (sentences 4-6) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 20536470, abstract (sentences 4-6) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 20536470, abstract (sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 20536470, abstract (sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 20536470, abstract (sentences 5-6) · 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).