Current partner codePEPTIDESDE
NCT00382174·Phase 2·INTERVENTIONAL

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Status

Completed

Phase

Phase 2

Enrollment

72

Locations

12

Results

Posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

Placebo

Topical administration of 0.00% thymosin beta 4 qd 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

Timeline

From registration to results.

  1. First posted

    Sep 28, 2006

  2. Study start

    May 2006

  3. Primary completion

    Dec 2008

  4. Study completion

    Dec 2008

  5. Results posted

    Feb 1, 2010

  6. Registry updated

    Feb 1, 2010

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Up to 84 days

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

Secondary outcomes

Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days

Time frame · Up to 84 days

Incidence of wound healing at the end of the study, Day 84

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
No

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.)

Study locations

12 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Institute for Advanced Wound Care

Montgomery, Alabama, United States

Impact Clinical Trials

Beverly Hills, California, United States

Long Beach VAMC

Long Beach, California, United States

Bay Pines VA Medical Center

Bay Pines, Florida, United States

A+ Research, Inc.

Miami, Florida, United States

Mount Dora Research Center, Inc.

Mt. Dora, Florida, United States

Hines VAMC

Hines, Illinois, United States

Wound Healing Laboratory Plastic Surgery UMass Medical Center

Worcester, Massachusetts, United States

New York Presbyterian Hospital

New York, New York, United States

University of North Carolina Hospital

Chapel Hill, North Carolina, United States

New Bridge Medical Center

Warren, Pennsylvania, United States

Mcguire VA Medical Center

Richmond, Virginia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Beta-4.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.