Intractable peripheral artery disease (arteriosclerosis obliterans and thronboangiitis obliterans) and intractable skin ulcer
Conditions
Interventions
Platelet rich plasma(PRP) will be prepared from autologous peripheral blood sample. Autologous PRP 1.8ml will be impregnated with biodegradable gelatin microsphere (180mg). Prepared controlled relea
Sponsors
Department of Cardiovascular Medicine, Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Intractable ulcer due to any cause, which complicated with disability of daily life. Intractable by means out of indication or no response to conventional medical treatment at least 3 months.
Exclusion criteria
Exclusion criteria: Any infections by osteomyelitis or multiple resistant bacteria, which unable to control by antibiotics alone. Any malignant disease, which was treated within 5 years. Who need treatment (surgical approach) in addition to present treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy determination by the changes of wound size and granulation recovery 4 weeks after treatment or termination period | — |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse event and resting pain | — |
Countries
Japan
Contacts
Public ContactGen Takagi
Nippon Medical School Department of Cardiovascular Medicine
Outcome results
None listed