JPRN-jRCTs043230043
Recruiting
Phase 1
Efficacy and Safety of Adipose Stem Cell Culture Supernatant Extract for Skin Ulcers
akagawa Masahiro0 sites80 target enrollmentJune 23, 2023
Conditionsskin ulcer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- skin ulcer
- Sponsor
- akagawa Masahiro
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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