Dermal Ulcer Refractory
Conditions
Interventions
Study arm: Autologous fibrin glue is given by spray with an amount prepared accoding to the size of ulcer, once a week, 1 to 4 weeks.
Control arm: bFGF is given by spray 5 times and covered with Bucl
Sponsors
Kawamoto Shinichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improved rate of surface area of the ulcer at 4 weeks after the initial treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Improved rate of the surface area of ulcer 2) Improved rate of the long est distance in right angle from 50% dividing baseline and the leng th of marginal line between ulcer and intact/improved skin. And the rate of improved surface area at the each evaluation points after 1,2,3, 4 weeks of initial treatment. | — |
Contacts
Public ContactShinichiro Kawamoto
Kobe University Hospital
Outcome results
None listed