chronic skin ulcers
Conditions
Interventions
Activated Platelet-Rich Plasma
Sponsors
Kansai Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged 20 years or older at informed consent. 2.Written informed consent. 3.Presence of chronic skin ulcers not healing for at least 1 month with conventional treatments. 4.Expected to be closed by autologous skin grafting or suturing after PRP treatment
Exclusion criteria
Exclusion criteria: 1.Patients showing unstable hemodynamics due to ischemic heart disease, or impair blood coagulation as in clotting disorders. 2.Patients taking anticoagulants or antithrombotics judged by the investigator or sub-investigator to be inappropriate as subjects since the drugs may affect the clotting system. 3.Have any of the following systemic diseases. *Uncontrolled diabetes mellitus:HbA1c not lower than 10% according to latest laboratory data obtained within 28 days before registration *Requiring continued use of oral corticosteroid therapy >20 mg/day prednisolone equivalent. *A history of malignant tumor with disease-free interval of 3 years or less 4.Patients who are or may be pregnant 5.Other patients judged by the investigator or sub-investigator to be inappropriate as a subject of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Time until wound closure The number of days from the administration of PRP to wound closure, spontaneous wound closure or wound closure by a simple surgical procedure is evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Percentage of wound reduction *The improvement of blood flow-The Skin perfusion pressure or Ankle brachial index *The correlation of Time until wound closure to the platelet count or growth factor levels in PRP | — |
Countries
Japan
Contacts
Public ContactNaoki Morimoto
Kansai Medical University Department of Plastic and Reconstructive Surgery
Outcome results
None listed