Study of Thymosin Beta 4 in Patients With Pressure Ulcers - Full Text View

Purpose

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

Condition	Intervention	Phase
Pressure Ulcers	Drug: Placebo Drug: Thymosin Beta 4	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Patients With Pressure Ulcers

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores

U.S. FDA Resources

Further study details as provided by RegeneRx Biopharmaceuticals, Inc.:

Primary Outcome Measures:

Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days [ Time Frame: Up to 84 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days [ Time Frame: Up to 84 days ] [ Designated as safety issue: No ]

Enrollment:	72
Study Start Date:	May 2006
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days	Drug: Placebo Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Active Comparator: 2 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 Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days

Detailed Description:

The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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

Exclusion Criteria:

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382174

Locations

United States, Alabama
Institute for Advanced Wound Care
Montgomery, Alabama, United States, 36111
United States, California
Impact Clinical Trials
Beverly Hills, California, United States, 90211
Long Beach VAMC
Long Beach, California, United States, 90822
United States, Florida
Bay Pines VA Medical Center
Bay Pines, Florida, United States, 33744
A+ Research, Inc.
Miami, Florida, United States, 33115
Mount Dora Research Center, Inc.
Mount Dora, Florida, United States, 32757
United States, Illinois
Hines VAMC
Hines, Illinois, United States, 60141
United States, Massachusetts
Wound Healing Laboratory Plastic Surgery UMass Medical Center
Worcester, Massachusetts, United States, 01655
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina Hospital
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
New Bridge Medical Center
Warren, Pennsylvania, United States, 16365
United States, Virginia
Mcguire VA Medical Center
Richmond, Virginia, United States, 23249

Sponsors and Collaborators

RegeneRx Biopharmaceuticals, Inc.

Investigators

Principal Investigator:

Terry Treadwell, MD

Institute for Advanced Wound Care

More Information

No publications provided

Responsible Party:	David Crockford, VP, Clinical and Regulatory Affairs, RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00382174 History of Changes
Other Study ID Numbers:	SSPU
Study First Received:	September 26, 2006
Results First Received:	December 29, 2009
Last Updated:	January 6, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by RegeneRx Biopharmaceuticals, Inc.:

pressure ulcers
cutaneous wound- healing
chronic wound-healing
Thymosin Beta 4
laminin-5

Additional relevant MeSH terms:

Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013