Refractory Skin UlcerNCT07016438
Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer
A study testing Transplant surgery in people with Refractory Skin Ulcer, run by PharmaBio Corporation at 1 site in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Refractory Skin Ulcer
- What is being tested?
- Transplant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteJapan
- Study dates
- 15 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (1) Patients with any of the following systemic diseases
- Poorly controlled diabetes mellitus (HbA1c greater than 10% at the most recent examination within 28 days prior to enrollment)
- Hypoalbuminemia (serum albumin level less than 2 g/dL)
- 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
- <!-- -->
- When local anesthesia is not appropriate for debridement due to scarring or hardness of the wound
Show all 17Show fewer
- 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)
- <!-- -->
- Hemoglobin less than 10.0 g/dL
- White blood cell count less than 3,000 /microliter
- Neutrophil count less than 1,500 / microliter
- 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)
- <!-- -->
- Total bilirubin 1.5x (upper limit of reference value) or higher
- AST (GOP) 3.0x (upper limit of reference value) or more
- ALT (GPT) 3.0x (upper limit of reference value) or more
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Kyoto University Hospital
Kyoto, Shogoin-kawahara-cho, Sakyo-ku, Kyoto, 606-8507
Hitoshi Kusano, M.D., +81 836-22-2428, ychiken@yamaguchi-u.ac.jp
About this study
Official title: Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer
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
- Refractory Skin Ulcer
- Being tested
- Transplant surgery
- Medical subject headings
- Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant surgeryProcedure or surgery
One piece of PAL-222 is implanted into the ulcer area through the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Therapeuitic group | Experimental | Not described Receives: Procedure: Transplant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main measures it aims to answer safety.
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Measured: 28days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Skin UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaBio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016438
- Sponsor's protocol ID
- PAL-222-P3
- Status last verified
- Jun 2025
- First submitted
- 8 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Clinical Study of PAL-222 Targeting Patients With Refractory Skin Ulcer
- ClinicalTrials.gov ID
- NCT07016438
- Acronym / sponsor ID
- PAL-222-P3
- Conditions
- Refractory Skin Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- PharmaBio CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapeuitic group | Experimental | Procedure: Transplant surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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
Key exclusion criteria (17 listed)
- (1) Patients with any of the following systemic diseases
- <!-- -->
- <!-- -->
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplant surgeryOne piece of PAL-222 is implanted into the ulcer area through the surgical procedure. | Procedure or surgery | Therapeuitic group |
Primary outcome
The main measures it aims to answer safety.
Time frame: 28days
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Refractory Skin Ulcer
RecruitingPhase 1/2
Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care
Diabetic Foot Ulcer (DFU)
Recruiting
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
Diabetic Foot Ulcer
RecruitingPhase 2
Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.
Systemic Sclerosis
Recruiting
Phase Ⅱ Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Venous Leg
Venous Leg Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplant surgery in people with Refractory Skin Ulcer, run by PharmaBio Corporation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hitoshi Kusano, M.D. (+81 44-589-6479, clinicaltrial@pharmabio.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main measures it aims to answer safety. (time frame: 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.