Pressure UlcersPhase 2NCT00382174
Study of Thymosin Beta 4 in Patients With Pressure Ulcers
A Phase 2 study testing Thymosin Beta 4 in people with Pressure Ulcers, run by RegeneRx Biopharmaceuticals, Inc. at 12 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Thymosin Beta 4
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2006to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Bay Pines VA Medical Center
Bay Pines, Florida, 33744
Impact Clinical Trials
Beverly Hills, California, 90211
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
Hines VAMC
Hines, Illinois, 60141
Long Beach VAMC
Long Beach, California, 90822
A+ Research, Inc.
Miami, Florida, 33115
Institute for Advanced Wound Care
Montgomery, Alabama, 36111
Mount Dora Research Center, Inc.
Mt. Dora, Florida, 32757
New York Presbyterian Hospital
New York, New York, 10032
Mcguire VA Medical Center
Richmond, Virginia, 23249
New Bridge Medical Center
Warren, Pennsylvania, 16365
Wound Healing Laboratory Plastic Surgery UMass Medical Center
Worcester, Massachusetts, 01655
About this study
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
The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers
Read the 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.
- Conditions
- Pressure Ulcers
- Being tested
- Placebo, Thymosin Beta 4
- Keywords
- pressure ulcers, cutaneous wound- healing, chronic wound-healing, Thymosin Beta 4, laminin-5
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Thymosin Beta 4Drug
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days Receives: Drug: Placebo |
| 2 | Active comparator | 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 Receives: Drug: Thymosin Beta 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 84 days
Secondary outcomes (1)
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
Incidence of wound healing at the end of the study, Day 84
Measured: Up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- RegeneRx Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Terry Treadwell, MD, Principal investigator, Institute for Advanced Wound Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382174
- Sponsor's protocol ID
- SSPU
- Status last verified
- Jan 2010
- First submitted
- 26 Sep 2006
- Last updated
- 1 Feb 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00382174
- Acronym / sponsor ID
- SSPU
- Conditions
- Pressure Ulcers
- Keywords
- pressure ulcers, cutaneous wound- healing, chronic wound-healing, Thymosin Beta 4, laminin-5
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- RegeneRx Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Posted 1 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo0.00% thymosin beta 4 w/w administered topically once daily for up to 84 days |
| 2 | Active comparator | Drug: Thymosin Beta 43 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTopical administration of 0.00% thymosin beta 4 qd up to 84 days | Drug | 1 |
| Thymosin Beta 4Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days | Drug | 2 |
Primary outcome
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
1 secondary outcome
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
Time frame: Up to 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pressure Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Treadwell, MD principal investigator
Institute for Advanced Wound Care
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymosin Beta 4 in people with Pressure Ulcers, run by RegeneRx Biopharmaceuticals, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days (time frame: Up to 84 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2010.