Trial · NCT00382174

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

NCT00382174, Phase 2, Completed, RegeneRx Biopharmaceuticals, Inc.; results first posted 2010-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Thymosin Beta 4 in Patients With Pressure Ulcers. Trials, record NCT00382174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00382174

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 Pressure Ulcers
NCT number: NCT00382174
Status: Completed
Phases: Phase 2
Enrollment: 72 participants, actual
Lead sponsor: RegeneRx Biopharmaceuticals, Inc.
Conditions: Pressure Ulcers
Interventions: Placebo, Thymosin Beta 4
First posted: 2006-09-28
Last updated: 2010-02-01
Results first posted: 2010-02-01

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 for up to 84 Days	Up to 84 days	All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population
Secondary	Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	Up to 84 days	Incidence of wound healing 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 for up to 84 Days	Up to 84 days		participants	NUMBER
SECONDARY	Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	Up to 84 days	Analysis was per protocol,ITT, and using LOCF	Number of healed participants	NUMBER

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days	Placebo	18	participants
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days	Tβ4 at 3 Doses	53	participants
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days	Placebo vs. Thymosin Beta 4 at 3 Doses	71	participants
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	Placebo	3	Number of healed participants
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	Tβ4 at 3 Doses	8	Number of healed participants
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days	Placebo vs. Thymosin Beta 4 at 3 Doses	11	Number of healed participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	18
Overall Study	STARTED	Tβ4 at 3 Doses	54
Overall Study	STARTED	Placebo vs. Thymosin Beta 4 at 3 Doses	72
Overall Study	COMPLETED	Placebo	14
Overall Study	COMPLETED	Tβ4 at 3 Doses	37
Overall Study	COMPLETED	Placebo vs. Thymosin Beta 4 at 3 Doses	51
Overall Study	NOT COMPLETED	Placebo	4
Overall Study	NOT COMPLETED	Tβ4 at 3 Doses	17
Overall Study	NOT COMPLETED	Placebo vs. Thymosin Beta 4 at 3 Doses	21

Source ClinicalTrials.gov

Adverse events348

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	Aneamia	Blood and lymphatic system disorders	Placebo	0	18	0
other	Aneamia	Blood and lymphatic system disorders	Tβ4 at 3 Doses	2	53	2
other	Aneamia	Blood and lymphatic system disorders	Placebo vs. Thymosin Beta 4 at 3 Doses	2	71	2
other	Angina Pectoris	Cardiac disorders	Placebo	0	18	0
other	Angina Pectoris	Cardiac disorders	Tβ4 at 3 Doses	1	53	1
other	Angina Pectoris	Cardiac disorders	Placebo vs. Thymosin Beta 4 at 3 Doses	1	71	1
other	Cardiac Failure Congestive	Cardiac disorders	Placebo	0	18	0
other	Cardiac Failure Congestive	Cardiac disorders	Tβ4 at 3 Doses	1	53	1
other	Cardiac Failure Congestive	Cardiac disorders	Placebo vs. Thymosin Beta 4 at 3 Doses	1	71	1
other	Adreanal Insufficiency	Eye disorders	Placebo	0	18	0

1 to 10 of 348Source ClinicalTrials.gov

See all 348 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Placebo
Total, all-cause mortality	Tβ4 at 3 Doses
Total, all-cause mortality	Placebo vs. Thymosin Beta 4 at 3 Doses
Total, other adverse events	Placebo	13
Total, other adverse events	Tβ4 at 3 Doses	40
Total, other adverse events	Placebo vs. Thymosin Beta 4 at 3 Doses	53
Total, serious adverse events	Placebo	5
Total, serious adverse events	Tβ4 at 3 Doses	13
Total, serious adverse events	Placebo vs. Thymosin Beta 4 at 3 Doses	18

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00382174

GET https://conductscience.org/api/trials/v1/NCT00382174/events?page=2

API reference For AI assistants