Autologous Fibrin Glue for Dermal Ulcer Treatment

Not Applicable

• Conditions: Dermal Ulcer; Refractory; D012883

• Registration Number: JPRN-jRCTs052190052
• Lead Sponsor: Kawamoto Shinichiro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-20
• Study Completion: 2021-03-12
• Results First Posted: 2023-11-17
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 2

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improved rate of surface area of the ulcer at 4 weeks after the initial treatment

Secondary Outcome Measures

Name	Time	Method
1) Improved rate of the surface area of ulcer<br>2) Improved rate of the long est distance in right angle from 50% dividing baseline and the leng th of marginal<br> line between ulcer and intact/improved skin. And the rate of improved surface area at the each evaluation <br> points after 1,2,3, 4 weeks of initial treatment.