Autologous Fibrin Glue for Dermal Ulcer Treatment

JRCT ID: jRCTs052190052

Registered date:20/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Dermal Ulcer
• Date of first enrollment: 14/04/2020
• Target sample size: 3
• Study type: Interventional

Intervention(s)

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 Bucladesine Sodium 4 weeks, once a day.

Outcome(s)

• Primary Outcome: Improved rate of surface area of the ulcer at 4 weeks after the initial treatment

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Kawamoto Shinichiro
• Source(s) of Monetary Support: Asahi Kasei Medical Co., Ltd.