Dermal Ulcer treatment with Autologous Fibrin Glue Study - DUALFIG Study

Kawamoto Shinichiro0 个研究点目标入组 2 人开始时间: 2019年9月20日最近更新: 2024年5月27日

适应症

试验速览

Autologous fibrine glue showed an efficacy for the treatment of refractory skin ulcer without adverse event.

•1. Patient of 20 years old or over.
•2. Patient with dermal ulcer between 2cm and 20cm in long diameter due to diseases such as,
•venous congestion, diabetes mellitus and vasculitis and that is not affected by load.
•3. Patient who requires treatment by bFGF and Bucladesine Sodium.
•4. Written informed consent

•1. Patient who does not meet the criteria in a guideline for autologous blood transfusion donation indicated
•by Japanese society of autologous blood transfusion except for the point that is applied for the surgery.
•2. Patient under treatment with anticoagulant that is not allowed interruption
•3. Patient who is deficienct in coagulation system
•4. Patient with past history of malignant disease at the region of the ulcers
•5. Patient with allergy against recombinant bFGF, Bucladesine Sodium and ethanol
•6. Patient with only an irregular shaped ulcer or an ulcer that includes difference in depth more than 5mm
•those are difficult to divide equally by a straight baseline
•7. Patient with a deep or large ulcer that requires surgical treatment
•8. Pregnant, possible pregnant and lactating female
•9. Participant of other clinical trials.
•10. Patient judged as inappropriate by physicians.

发起方

Kawamoto Shinichiro