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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
274
Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.
Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.
Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.
OrthoLogic
Tempe, Arizona, United States
Time to removal of all rigid immobilization for fracture
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Time to clinical healing of the fracture
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Time to radiographic healing of the fracture
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of range of motion relative to unbroken wrist
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of grip strength relative to unbroken wrist
Time frame: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Results of patient questionnaires
Time frame: Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment
Incidence of treatment-emergent adverse events
Time frame: Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment
Chemistry and hematology laboratory evaluations
Time frame: Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment
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Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.