NCT00382174

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 1, 2010

Completed
Last Updated

February 1, 2010

Status Verified

January 1, 2010

Enrollment Period

2.6 years

First QC Date

September 26, 2006

Results QC Date

December 29, 2009

Last Update Submit

January 6, 2010

Conditions

Pressure Ulcers

Keywords

pressure ulcerscutaneous wound- healingchronic wound-healingThymosin Beta 4laminin-5

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days

    All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population

    Up to 84 days

Secondary Outcomes (1)

  • Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days

    Up to 84 days

Study Arms (2)

1

PLACEBO COMPARATOR

0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days

Drug: Placebo

2

ACTIVE COMPARATOR

3 doses of thymosin beta 4: 0.01% w/w, 0.02% w/w, and 0.1% w/w, administered topically once daily for up to 84 days

Drug: Thymosin Beta 4

Interventions

PlaceboDRUG

Topical administration of 0.00% thymosin beta 4 qd up to 84 days

1
Thymosin Beta 4DRUG

Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days

2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent Form signed by the patient or patient's legal representative
  • Inpatients and outpatients
  • At least 1 PU with full-thickness skin loss and no joint capsule or bone exposure
  • Surface area between 5 and 70 cm2
  • Ulcer present and stable for at least 1 month before enrollment

You may not qualify if:

  • Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
  • Use of immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment. Systemic steroids not allowed 30 days prior to enrollment. Topical therapy other than steroidal is allowed up to 7 days prior to enrollment
  • History of adverse events to any ingredients of study medication
  • Neurological, cardiovascular, respiratory, hepatic, renal, or metabolic disease likely to interfere with the patient's participation in or completion of the study
  • Arterial or venous disorder resulting in ulcerated wounds
  • Diabetes mellitus except if disease is determined to be under control with a glycosylated hemoglobin ≤8.5% of total hemoglobin
  • Pregnancy or breastfeeding during the study. (A serum pregnancy test will be performed at Screening for female patients of childbearing potential.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Institute for Advanced Wound Care

Montgomery, Alabama, 36111, United States

Location

Impact Clinical Trials

Beverly Hills, California, 90211, United States

Location

Long Beach VAMC

Long Beach, California, 90822, United States

Location

Bay Pines VA Medical Center

Bay Pines, Florida, 33744, United States

Location

A+ Research, Inc.

Miami, Florida, 33115, United States

Location

Mount Dora Research Center, Inc.

Mt. Dora, Florida, 32757, United States

Location

Hines VAMC

Hines, Illinois, 60141, United States

Location

Wound Healing Laboratory Plastic Surgery UMass Medical Center

Worcester, Massachusetts, 01655, United States

Location

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27599, United States

Location

New Bridge Medical Center

Warren, Pennsylvania, 16365, United States

Location

Mcguire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

thymosin beta(4)

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Nabila Turjman, PhD, Executive Director, Regulatory Affairs
Organization
RegeneRx Biopharmaceuticals, Inc.
nturjman@regenerx.com
301-280-1992

Study Officials

  • Terry Treadwell, MD

    Institute for Advanced Wound Care

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 28, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

February 1, 2010

Results First Posted

February 1, 2010

Record last verified: 2010-01

Locations

US(12)