Radius Fracture
Conditions
Keywords
Chrysalin, TP508, Fracture, Wrist, Healing
Brief summary
The purpose of this study is to evaluate the safety of Chrysalin, also known as TP508, and to determine the effectiveness of four doses of Chrysalin for treating broken wrists in adults.
Detailed description
There is a medical need for a product that is safe and can accelerate the rate of bone healing, leading to a reduction in immobilization time. Chrysalin, also known as TP508, is a synthetic peptide (protein) that is an exact copy of part of the human protein thrombin, which is a protein that occurs naturally in the body. Chrysalin can be used to mimic part of the thrombin response after injury without stimulating any of the events associated with blood clotting, and can therefore accelerate the normal process of healing.
Interventions
DRUGChrysalin
Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
DRUGPlacebo
Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.
Sponsors
Capstone Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* An unstable and/or displaced fracture of the distal radius * Fracture classified as primary intra-articular or extra-articular * Male, or non-pregnant, non-lactating female at least 18 years old. If female of childbearing potential, must have confirmed negative pregnancy test prior to administration of study product. Must agree to use a medically approved method of birth control for 6 months. * Need ability to understand study requirements, provide written informed consent, and comply with study protocol * Need ability to understand and provide written authorization for use and disclosure of health information per Health Insurance Portability and Accountability Act (HIPAA)
Exclusion criteria
* History of distal radius fracture of the affected limb 2 years prior to study enrollment * History of uncontrolled Type I or Type II diabetes mellitus * History or clinical evidence of any active medical disease or condition which would make the subject, in the opinion of the investigator, unsuitable for the study, or could potentially confound the results of the study * Concurrent use of other investigational (non-Food and Drug Administration \[FDA\]-approved) agent or device * Participation in any other clinical study within 90 days prior to treatment with the study drug * Female subjects who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to removal of all rigid immobilization for fracture | Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time to radiographic healing of the fracture | Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment |
| Assessment of range of motion relative to unbroken wrist | Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment |
| Assessment of grip strength relative to unbroken wrist | Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment |
| Time to clinical healing of the fracture | Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment |
| Incidence of treatment-emergent adverse events | Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment |
| Chemistry and hematology laboratory evaluations | Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment |
| Results of patient questionnaires | Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment |
Countries
United States
Outcome results
None listed