Pressure Ulcers
Conditions
Keywords
pressure ulcers, cutaneous wound- healing, chronic wound-healing, Thymosin Beta 4, laminin-5
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.
Interventions
DRUGPlacebo
Topical administration of 0.00% thymosin beta 4 qd up to 84 days
DRUGThymosin Beta 4
Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days
Sponsors
RegeneRx Biopharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days | Up to 84 days | All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days | Up to 84 days | Incidence of wound healing at the end of the study, Day 84 |
Countries
United States
Participant flow
Recruitment details
Recruitment started in 2005 and ended in 2008 using 13 sites: Medical Center Clinics, Wound Care Center, Veteran Administration Centers, and Clinical Research Centers.
Pre-assignment details
Prior to randomization, patients needed to meet specific inclusion and exclusion criteria: results of pregnancy tests needed to be negative; glycosylated hemoglobin tests needed to be less or equal to 8.5% of the total hemoglobin.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w) | 18 |
| Tβ4 at 3 Doses 0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w | 54 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 4 | 5 |
| Overall Study | Failed to meet criteria | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 4 | 5 |
| Overall Study | Non compliance | 1 | 0 | 1 |
| Overall Study | Physician Decision | 0 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 5 |
| Overall Study | Wounds merged | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo | Tβ4 at 3 Doses | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 16 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 38 Participants | 55 Participants |
| Region of Enrollment United States | 18 participants | 54 participants | 72 participants |
| Sex: Female, Male Female | 2 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Male | 16 Participants | 40 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / — | 40 / — | 53 / — |
| serious Total, serious adverse events | 5 / — | 13 / — | 18 / — |
Outcome results
Primary
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
Time frame: Up to 84 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days | 18 participants |
| Tβ4 at 3 Doses | Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days | 53 participants |
| Placebo vs. Thymosin Beta 4 at 3 Doses | Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days | 71 participants |
Secondary
Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days
Incidence of wound healing at the end of the study, Day 84
Time frame: Up to 84 days
Population: Analysis was per protocol,ITT, and using LOCF
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days | 3 Number of healed participants |
| Tβ4 at 3 Doses | Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days | 8 Number of healed participants |
| Placebo vs. Thymosin Beta 4 at 3 Doses | Wound Healing Effectiveness of Tβ4 Applied for up to 84 Days | 11 Number of healed participants |