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Study of Thymosin Beta 4 in Patients With Pressure Ulcers

Primary Purpose

Pressure Ulcers

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Thymosin Beta 4
Sponsored by
RegeneRx Biopharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcers focused on measuring pressure ulcers, cutaneous wound- healing, chronic wound-healing, Thymosin Beta 4, laminin-5

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Institute for Advanced Wound Care
  • Impact Clinical Trials
  • Long Beach VAMC
  • Bay Pines VA Medical Center
  • A+ Research, Inc.
  • Mount Dora Research Center, Inc.
  • Hines VAMC
  • Wound Healing Laboratory Plastic Surgery UMass Medical Center
  • New York Presbyterian Hospital
  • University of North Carolina Hospital
  • New Bridge Medical Center
  • Mcguire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
Incidence of wound healing at the end of the study, Day 84

Full Information

First Posted
September 26, 2006
Last Updated
January 6, 2010
Sponsor
RegeneRx Biopharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00382174
Brief Title
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

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
RegeneRx Biopharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
pressure ulcers, cutaneous wound- healing, chronic wound-healing, Thymosin Beta 4, laminin-5

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Intervention Type
Drug
Intervention Name(s)
Thymosin Beta 4
Intervention Description
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
Primary Outcome Measure Information:
Title
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days
Description
All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population
Time Frame
Up to 84 days
Secondary Outcome Measure Information:
Title
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
Description
Incidence of wound healing at the end of the study, Day 84
Time Frame
Up to 84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Treadwell, MD
Organizational Affiliation
Institute for Advanced Wound Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Advanced Wound Care
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Impact Clinical Trials
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Long Beach VAMC
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Bay Pines VA Medical Center
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
A+ Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33115
Country
United States
Facility Name
Mount Dora Research Center, Inc.
City
Mount Dora
State/Province
Florida
ZIP/Postal Code
32757
Country
United States
Facility Name
Hines VAMC
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Wound Healing Laboratory Plastic Surgery UMass Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
New Bridge Medical Center
City
Warren
State/Province
Pennsylvania
ZIP/Postal Code
16365
Country
United States
Facility Name
Mcguire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

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Study of Thymosin Beta 4 in Patients With Pressure Ulcers

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