Completed

Phase 2

Age: 18Years - 85Years

All Genders

ID00382174

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

Led by RegeneRx Biopharmaceuticals, Inc. · Updated on 2010-02-01

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What This Trial Is About

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

CONDITIONS

Brief Title

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Who Can Participate

Age: 18Years - 85Years

All Genders

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.)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

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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

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Sponsors

AI-Summary

What This Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

How is the study designed?

Not the Right Trial for You?

On this page

Sponsors

Sponsors

Who Can Participate

Eligibility Criteria

How is the study designed?

Sponsors