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Efficacy and Safety of Adipose Stem Cell Culture Supernatant Extract for Skin Ulcers

Phase 1
Recruiting
Conditions
skin ulcer
Registration Number
JPRN-jRCTs043230043
Lead Sponsor
akagawa Masahiro
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
Inclusion Criteria

1. men and women between 18 and 90 years of age
2. patients with various types of skin ulcers (excluding head and face)
3. patients with skin ulcers with a maximum diameter of 1 cm or more but less than 9 cm
4. patients whose consent to participate in this study has been obtained by signing a consent form by the patient or a proxy.

Exclusion Criteria

1. patients with vasculitic ulcers
2. patients requiring inpatient treatment for ulcers
3. patients with severe anemia or thrombocytopenia
4. patients with infection at the site of ulcer and tendency to exacerbation
5. patients with malignant tumors at the ulcer site
6. patients requiring surgical procedures such as amputation or skin grafting (not including debridement)
7. patients receiving continuous oral or injectable steroid hormone therapy
8. patients with severely impaired nutritional status
9. patients undergoing dialysis or immunosuppression
10. who has a history of allergy to adipose stem cell culture supernatant extract
11. patients who have been deemed unsuitable by the principal investigator or a subinvestigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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