Trial · NCT00832091
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
NCT00832091, Phase 2, Completed, RegeneRx Biopharmaceuticals, Inc.; results first posted 2010-03-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers. Trials, record NCT00832091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00832091
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
- NCT number
- NCT00832091
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- RegeneRx Biopharmaceuticals, Inc.
- Conditions
- Venous Stasis Ulcers
- Interventions
- Thymosin Beta 4, Placebo
- First posted
- 2009-01-29
- Last updated
- 2010-03-30
- Results first posted
- 2010-03-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days | Up to 84 days | All Treatment-Emergent (TE) Serious Adverse Events (SAEs) and Adverse Events (AEs) by treatment with Tβ4 gel at the combined 3 doses in the safety population with Venous Stasis (VS) ulcers for up to 84 days. TEAE is defined as a side effect that begins or that worsens in severity after the application of at least one dose of Tβ4 gel on the venous stasis ulcer. A pre-existing condition is not considered an AE, but if it worsens during the study, then it may be considered an AE |
| Secondary | Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers | Up to 84 days | Wound healing effectiveness of Tβ4 gel applied once daily for up to 84 days to patients expressed as the number of patients whose wound had closed without drainage at the end of the study, Day 84 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days | Up to 84 days | Analysis per protocol, ITT, using LOCF | SAEs and AEs | NUMBER |
| SECONDARY | Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers | Up to 84 days | Analysis per protocol, Intent-to-treat (ITT), using Last Observation Carried Forward (LOCF) | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days | Placebo | 24 | SAEs and AEs | ||
| Safety and Tolerability of Thymosin Beta 4 (Tβ4) Applied to Patients With Venous Stasis (VS) Ulcers for up to 84 Days | Thymosin Beta 4 (Tβ4) at 3 Doses | 104 | SAEs and AEs | ||
| Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers | Placebo | 4 | Participants | ||
| Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers | Thymosin Beta 4 (Tβ4) at 3 Doses | 12 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | STARTED | Thymosin Beta 4 (Tβ4) at 3 Doses | 55 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | COMPLETED | Thymosin Beta 4 (Tβ4) at 3 Doses | 53 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Thymosin Beta 4 (Tβ4) at 3 Doses | 2 |
Source ClinicalTrials.gov
Adverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mycobacterium ulcerans infection | Infections and infestations | Placebo | 0 | 17 | 0 |
| other | Mycobacterium ulcerans infection | Infections and infestations | Thymosin Beta 4 (Tβ4) at 3 Doses | 1 | 55 | 1 |
| other | Red blood cell sedimentation rate increased | Investigations | Placebo | 0 | 17 | 0 |
| other | Red blood cell sedimentation rate increased | Investigations | Thymosin Beta 4 (Tβ4) at 3 Doses | 6 | 55 | 6 |
| other | alanine aminotransferase increased | Investigations | Placebo | 0 | 17 | 0 |
| other | alanine aminotransferase increased | Investigations | Thymosin Beta 4 (Tβ4) at 3 Doses | 1 | 55 | 1 |
| other | bilirubin conjugated increased | Investigations | Placebo | 0 | 17 | 0 |
| other | bilirubin conjugated increased | Investigations | Thymosin Beta 4 (Tβ4) at 3 Doses | 1 | 55 | 1 |
| other | blood calcium decreased | Investigations | Placebo | 0 | 17 | 0 |
| other | blood calcium decreased | Investigations | Thymosin Beta 4 (Tβ4) at 3 Doses | 1 | 55 | 1 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Thymosin Beta 4 (Tβ4) at 3 Doses | ||
| Total, other adverse events | Placebo | 11 | 17 |
| Total, other adverse events | Thymosin Beta 4 (Tβ4) at 3 Doses | 35 | 55 |
| Total, serious adverse events | Placebo | 1 | 17 |
| Total, serious adverse events | Thymosin Beta 4 (Tβ4) at 3 Doses | 3 | 55 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thymosin Beta 4 (Tβ4) at 3 Doses vs Placebo: Wound Healing (Wound Closure Without Drainage) by Applying Tβ4 Gel Once Daily for up to 84 Days to Patients With Venous Stasis (VS) Ulcers | Trial comparisons |
| Thymosin Beta 4 (Tβ4) at 3 Doses vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00832091
GET https://conductscience.org/api/trials/v1/NCT00832091/events?page=2