Back to profileComponent study · 2010

Thymosin-beta-4 venous-ulcer trial

The effect of thymosin treatment of venous ulcers.

Guarnera G, DeRosa A, Camerini R, 8 European sites. · Annals of the New York Academy of Sciences

Study record

Population

73 patients with venous stasis ulcers randomized at eight European sites: five in Italy and three in Poland.

Read source · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Formulation

Topically administered synthetic 43-amino-acid thymosin-beta-4. Exact preparation and all dose-arm details require full text.

Inspect extraction gap · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Route

Topical ulcer treatment.

Read source · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Dose & frequency

Abstract highlights a possible 0.03% concentration signal but omits all tested doses, amount and frequency. No human or KLOW regimen established.

Inspect extraction gap · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Study design

Phase 2 double-blind placebo-controlled dose-escalation trial. Allocation details and analysis populations unavailable in abstract. Linkage to a similarly described registered trial is unverified; its results are not merged with this publication.

Read source · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Duration

Healing discussed within three months. Exact dosing schedule, stopping rules and later follow-up not available.

Inspect extraction gap · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Reported findings

Authors suggest 0.03% may accelerate healing, especially smaller or less severe wounds, with approximately 25% complete healing within three months. Abstract omits arm-specific counts and statistical comparisons; this is not an established 25-percentage-point benefit over placebo.

Read source · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Adverse events

Authors describe safety as acceptable and comparable to placebo, but abstract supplies no event counts, severity distribution or ascertainment methods.

Inspect extraction gap · Abstract-level extractionPrimary abstract — clinical report; full text unavailable
Monitoring

Ulcer healing and safety evaluated; assessment schedule and measurement methods not extracted.

Inspect extraction gap · Abstract-level extractionPrimary abstract — clinical report; full text unavailable

What it supports

Limited formulation- and indication-specific human evidence.

What it does not establish

Abstract-level report; cannot establish systemic TB-500, peptide pairing, KLOW efficacy or long-term safety. No cross-study dose substitution.

Funding

Not reported in available abstract.

Literature search cutoff: 2026-09-08 · Not independently clinically reviewed

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