Actively Recruiting
Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer
Led by PharmaBio Corporation · Updated on 2025-06-11
6
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess safety and efficacy in patients with with Refractory skin ulcer no response to existing therapy. The main measures it aims to answer are: * Investigation of adverse events * Changes in clinical testing data * Changes in vital signs Participants will have one PAL-222 transplanted to the ulcer site. Researchers will compare before and after the transplantation to see if any safety issues are recognized.
CONDITIONS
Official Title
Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 20 years or older at the time of consent
- Patients with skin ulcers showing less than 50% size reduction after 4 weeks or more of standard treatment
- Ulcer size between 1 cm² and 3 cm² after debridement
- Ulcer located within 5 cm from the treatment site
- No signs of local infection in the ulcer area
- Bone exposure, if present, must be within 10% of the ulcer area
- Skin reflux pressure of 30 mmHg or more at the treatment site (for ulcers on lower leg or foot)
- Patients who have been fully informed about the trial and given written consent
- Patients able to follow oral or written instructions from investigators
You will not qualify if you...
- Poorly controlled diabetes mellitus (HbA1c greater than 10% within 28 days before enrollment)
- Low serum albumin level (less than 2 g/dL)
- Need for continuous oral steroids exceeding 10 mg prednisolone per day
- Need for general or lumbar anesthesia during the study due to wound scarring or inability to keep the wound at rest
- History of allergy to human serum albumin, trypsin, study anesthetics, antiseptics, or covering materials
- Abnormal blood, coagulation, or urine test results that would affect study participation
- Positive tests for HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, or syphilis at screening
- Severe blood disorders including low hemoglobin, white blood cell count, neutrophil count, or platelet count
- Severe heart failure (NYHA class III-IV)
- Severe liver impairment or related conditions
- Severe kidney impairment (creatinine over 2 mg/dL)
- Malignancy diagnosis or treatment within 5 years prior to consent
- Pregnant or lactating women or those planning pregnancy during the study
- Inability to discontinue anticoagulant or antiplatelet medications prior to the trial
- Drug addiction or alcoholism
- Current participation in another clinical trial
- Previous participation in this trial with PAL-222 implantation
- Investigator's judgment of unsuitability for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Kyoto University Hospital
Kyoto, Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan, 606-8507
Actively Recruiting
Research Team
H
Hitoshi Kusano, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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