Clinical trial NCT00382174: Study of Thymosin Beta 4 in Patients With Pressure Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pressure Ulcers
Keywords: pressure ulcers
cutaneous wound- healing
chronic wound-healing
Thymosin Beta 4
laminin-5
Lead sponsor: RegeneRx Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.)

Primary outcomes:
measure: Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days
timeFrame: Up to 84 days
Secondary outcomes:
measure: Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
timeFrame: Up to 84 days
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Institute for Advanced Wound Care
state: Alabama
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: Long Beach
country: United States
facility: Long Beach VAMC
state: California
city: Bay Pines
country: United States
facility: Bay Pines VA Medical Center
state: Florida
city: Miami
country: United States
facility: A+ Research, Inc.
state: Florida
city: Mount Dora
country: United States
facility: Mount Dora Research Center, Inc.
state: Florida
city: Hines
country: United States
facility: Hines VAMC
state: Illinois
city: Worcester
country: United States
facility: Wound Healing Laboratory Plastic Surgery UMass Medical Center
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Warren
country: United States
facility: New Bridge Medical Center
state: Pennsylvania
city: Richmond
country: United States
facility: Mcguire VA Medical Center
state: Virginia
Study officials:
affiliation: Institute for Advanced Wound Care
name: Terry Treadwell, MD
role: PRINCIPAL_INVESTIGATOR
References: