Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer

Launched by PHARMABIO CORPORATION · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PAL-222 for patients with refractory skin ulcers, which are wounds that haven't healed despite receiving standard care for at least four weeks. The main goal of the study is to see if PAL-222 is safe and effective in helping these ulcers heal by comparing the condition of the ulcers before and after the treatment. Participants will receive a transplant of PAL-222 directly to their ulcer site, and researchers will monitor for any side effects, changes in health data, and vital signs throughout the study.

To be eligible for this trial, patients need to be at least 20 years old and have a skin ulcer that has not improved significantly after standard treatment. There are also specific health criteria that must be met, such as not having certain serious medical conditions, infections, or allergies that could complicate the treatment. Participants can expect to receive close monitoring and care from the research team, and they must be able to follow instructions and provide informed consent before taking part in the trial. This is a great opportunity for those struggling with stubborn skin ulcers to potentially benefit from a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • (1) Patients aged 20 years or older at the time of obtaining consent (2) Patients with skin ulcers whose ulcer size has decreased by less than 50% compared to before the start of treatment even after 4 weeks or more of conservative standard treatment (3) Patients with an ulcer of 1 cm2 or more and 3 cm2 or less after debridement (4) Patients with ulcers within 5 cm from the ulcer to be treated (5) Patients with no signs of local infection in the ulcer to be treated (6) If the ulcer had the bone exposure, it needs to be within 10% of the ulcer area (7) Patients with skin reflux pressure of 30 mmHg or more at the treatment site (if the patient has an ulcer on the lower leg or foot) (8) Patients who have received a written explanation of this clinical trial from the principal investigator or clinical investigator, fully understood the information, and given their own written consent to participate in this clinical trial (9) Patients who are able to follow oral or written instructions from the principal investigator or clinical investigator
• Exclusion Criteria:
• • (1) Patients with any of the following systemic diseases
• • 1. Poorly controlled diabetes mellitus (HbA1c greater than 10% at the most recent examination within 28 days prior to enrollment)
• • 2. Hypoalbuminemia (serum albumin level less than 2 g/dL)
• • 3. Patients requiring continuous oral steroids (prednisolone equivalent greater than 10 mg per day) (2) Patients requiring general anesthesia or lumbar anesthesia during the study period for the following reasons
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• • 1. When local anesthesia is not appropriate for debridement due to scarring or hardness of the wound
• • 2. Patients who are mentally disturbed, have involuntary movements, or are unable to keep the wound at rest during transplantation (3) Patients with a history of allergy to human serum albumin, trypsin, anesthetics used in this study, antiseptics, or covering materials (4) Patients with abnormal findings on hematology, hematochemistry, coagulation, or urinalysis at the time of screening that would be problematic for participation in the clinical trial (5) Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, or syphilis serology at screening (6) Patients with severe blood disorders (if any of the following criteria are met)
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• • 1. Hemoglobin less than 10.0 g/dL
• • 2. White blood cell count less than 3,000 /microliter
• • 3. Neutrophil count less than 1,500 / microliter
• • 4. Platelet count less than 75,000 / microliter (7) Patients with severe heart failure (NYHA cardiac function classification III-IV) (8) Patients with severe hepatic impairment (with a history of or complicated by fulminant hepatitis, cirrhosis, liver tumor, or any of the following criteria)
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• • 1. Total bilirubin 1.5x (upper limit of reference value) or higher
• • 2. AST (GOP) 3.0x (upper limit of reference value) or more
• • 3. ALT (GPT) 3.0x (upper limit of reference value) or more
• • 4. ALP 2.5x (upper limit of reference value) or higher (9) Patients with severe renal impairment (creatinine greater than 2 mg/dL) (10) Patients diagnosed with or requiring treatment for malignancy within 5 years prior to obtaining consent (11) Pregnant or lactating women, or patients who wish to become pregnant during the study period (12) Patients whose anticoagulant or antiplatelet medication cannot be discontinued prior to the clinical trial, as determined by the attending physician of the relevant department (13) Patients with drug addiction or alcoholism (14) Patients who are currently participating in another clinical trial (15) Patients who have participated in this clinical trial once and had PAL-222 implanted (16) Patients who are judged to be inappropriate as subjects by the investigator or subinvestigator