Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Drug: Placebo
* Drug: Thymosin Beta 4


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days | Drug: Placebo<br>* Topical administration of 0.00% thymosin beta 4 qd up to 84 days<br>|
| Active Comparator: 2<br>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<br>* Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days | Incidence of wound healing at the end of the study, Day 84 | Up to 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pressure ulcers, cutaneous wound- healing, chronic wound-healing, Thymosin Beta 4, laminin-5