refractory ulcer refractory ulcer, Platelet rich plasma
Conditions
Interventions
The patient's own blood is collected and PRP is obtained by an automated
autologous platelet centrifuge (Magellan
Arteriocyte Medical Systems,
Inc., Cleveland, USA). In general adults, for 10 x 10 cm target ulcer,
blood collection volume is 30-60 mL, and approximately 3-6 mL of
platelet-rich plasma (PRP) is obtai
Sponsors
Shimada Kenichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with refractory skin ulcers that are not improved or are exacerbated by conventional treatments, and who are difficult to treat by surgery due to physical condition, etc. Patients over 20 years of age who have obtained a written consent of their own free will (1)Refractory ulcer resistant to conservative treatment (2)Patients who refuse to undergo surgical procedures such as amputation and skin grafting, or patients whose general condition is poor enough for the anesthesiologist to determine that the surgery is inappropriate (3)Patients who can collect blood for PRP preparation (4)Being an adult over 20 years old (5)Patients who have obtained written consent from the subject (or surrogate) before collecting blood for PRP preparation
Exclusion criteria
Exclusion criteria: Patients with advanced anemia, thrombocytopenia, etc., who are judged inappropriate as subjects by the investigator (1)Patients who have wound surface with uncontrollable infection (if the infection is suspected due to the color of the wound, the color of the pus, or the smell, the presence of infection is determined by culturing the bacteria) (2)Patients with malignant tumor on the wound surface (ulcer) (3)Significant anemia (Hb <7g / dL for both men and women) (4)leukemia (5)Aplastic anemia (6)Thrombocytopenia (7)Patients diagnosed with abnormal blood coagulation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate: The response rate is calculated by defining a case where the area reduction rate at the final visit during the PRP implementation period exceeds 50% before the start of this study as a response. * Since the reduction of the wound area is the primary goal for treatment of intractable skin ulcers, the evaluation index for the area reduction rate was set with reference to information on the approved preparations for treatment of pressure ulcers and skin ulcers. The ulcer area reduction rate is also calculated and evaluated. Evaluate changes in ulcer area and properties at the time of each observation (diagnosis after 1 week, 4 weeks, 3 months, and 6 months after administration). | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the safety of PRP therapy (adverse events, serious adverse events, frequency of failures). | — |
Countries
Japan
Contacts
Public ContactNaomi Masuda
Kanazawa Medical University Hospital
Outcome results
None listed