Pressure UlcerPhase 2NCT05199077
A Study of GM-XANTHO in Pressure Ulcer Patients
A Phase 2 study testing GM-XANTHO in people with Pressure Ulcer and Diabetes Mellitus, run by Xantho Biotechnology Co., LTD at 1 site in Taiwan.
Trial summary
This is a randomized, placebo-controlled, double-blind, 3-arm, single-center, phase IIa, parallel study to assess the efficacy, safety, and tolerability of topically applied 2.5%, 5% GM-XANTHO plus standard of care in patients with stage II or stage III pressure ulcer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pressure Ulcer, Diabetes Mellitus
- What is being tested?
- GM-XANTHO
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 30 Apr 2029
- Phase
- Phase 2
- 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. Female or male inpatients including in those staying in a long-term care facility, age ≥ 20 years old.
- 2. Patient who is able to understand the nature of this study and accepts to enter the study by signing written informed consent.
- 3. Patient is willing to comply with protocol-stated requirements, instructions and restrictions.
- 4. Patients who have at least 1 well diagnosed Stage 2 to 3 friction-injury associated PU (according to National Pressure Ulcer Advisory Panel [NPUAP] Staging Guidelines, 2019) as the index ulcer at Screening Visit and First Dosing Visit located in any of the following regions.
- 5. Surface dimensions of the index PU should be ≥ 5 cm2 and ≤ 50 cm2 as measured by the greatest length and width method through using an mm-scale ruler.
- 6. Patients with adequate arterial blood flow and perfusion near the site of the injury for lower extremity ulcers (e.g., the foot is warm to the touch and has palpable pulses) 7. Patients who agree discontinuation of systemic corticosteroids and systemic immune modulating agents during the study period 8. Patients who agree discontinuation of all local treatment modalities, including but not limited to topical antimicrobials, topical corticosteroid or light treatments during the study period for/on the index wound.
Show all 22Show fewer
- 9. Patients are required to stop using treatment modalities listed in Criteria #7 and #8 at least 14 days (or longer if the treatment half-life requires so; 7 half-life should have elapsed).
- 10. Patient has adequate hematopoietic, hepatic function, nutrition condition and renal function as assessed by the following laboratory requirements to be conducted within 28 days prior to the first dosing:
- Hemoglobin ≥ 10 g/dL
- Total WBC ≥ 3,000 cells/μL
- Platelet ≥ 55,000 counts/μL without transfusion support
- Total bilirubin ≤ 1.5× ULN and no sign of jaundice
- ALT and AST ≤ 5× ULN and no clinical significance
- pre-albumin ≥ 11 mg/dL
- Creatinine ≤ 1.5× ULN and no clinical significance 11. If the subject has diabetes mellitus [as per American Diabetes Association guidelines (ADA guideline, 2021)], the hemoglobin A1c (HbA1c) should be≦10 % with a stable anti-diabetes regimen (monotherapy or combination therapy including oral anti-diabetes medications) for more than 12 weeks.
- 12. All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods shown below, for during and at least 4 weeks after GM-XANTHO treatment.
- Total abstinence [when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization. For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
- Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
- d.1 Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- d.2 Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3 Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Who cannot join
- 1. Surgical treatment of pressure ulcers within 30 days prior to the Screening Visit.
- 2. Patients who have any concurrent skin condition that will interfere with assessment of treatment or any condition associated with a wound healing abnormality (e.g.: connective tissue disorder or immune disorder).
- 3. Patients who have active infection on the PU site(s) at baseline 4. Patients who have known hypersensitivity to the study medication 5. Patients with chronic condition(s) which either is not stable or not well controlled.
- 6. Patients having positive results for HBV, HCV or HIV screens 7. Patients who are pregnant or breast feeding 8. Patients carry history of malignancy of any organ system (other than cervical carcinoma in situ or localized prostate cancer) within 5 years prior to study entry.
- 9. Patients had participated in investigational drug trials and took any investigational drugs within 30 days or within 5 half-life of the investigational drugs prior to the screening visit.
- 10. Patients who are not suitable to participate in the trial as judged by the Investigator(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO in Pressure Ulcer Patients
This is a randomized, placebo-controlled, double-blind, 3-arm, single-center, phase IIa, parallel study to assess the efficacy, safety, and tolerability of topically applied 2.5%, 5% GM-XANTHO plus standard of care in patients with stage II or stage III pressure ulcer.
Read the detailed description
This is a randomized, placebo-controlled, double-blind,three-arm, single-centered, parallel study to evaluate the efficacy and safety profiles of the topical ointment, GM-XANTHO. For placebo group and cohort A, at least 30% eligible subjects with DM will be enrolled, for cohort B, only eligible subjects with DM will be enrolled.
Patients with pressure ulcer will be instructed to apply appropriate amount of placebo ( 3.2 mg/cm 2, for placebo group) 2.5 % GM-XANTHO [3.2 mg/cm 2, for cohort A ], or 5% GM-XANTHO [3.2 mg/cm 2, for cohort B] ointment once a day for 28 days. The appropriate dressings that maintain a moist wound as a standard background intervention.
For primary endpoint, the wound completed healing rate of the target lesion will be continuously observed to evaluate the efficacy. For secondary endpoints, the efficacy profile of GM-XANTHO will be assessed by the healing time, recurrent time and recurrent rate. The baseline of each efficacy factors will be evaluated on Day 1 before dosing.
- Conditions
- Pressure Ulcer, Diabetes Mellitus
- Being tested
- GM-XANTHO
- Keywords
- Pressure Ulcer
- Medical subject headings
- Pressure Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-XANTHODrug
Also called Placebo
a topical applied ointment
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Topical administration of a drug-free placebo ointment daily for 28 days. Receives: Drug: GM-XANTHO |
| cohort A | Active comparator | Topical administration of a 2.5 % GM-XANTHO ointment daily for 28 days. Receives: Drug: GM-XANTHO |
| cohort B | Active comparator | Topical administration of a 5 % GM-XANTHO ointment daily for 28 days. Receives: Drug: GM-XANTHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change
percentage change in ulcer area
Measured: 112 days
Secondary outcomes (13)
Time to complete wound closure
The time from the baseline to the complete healing of the target lesion
Measured: 112 days
The incidence of complete wound closure of the target lesion.
The percentage of subjects that achieved complete wound closure from baseline at each visit.
Measured: 112 days
Time to Recurrence
The time from when the target lesion is completely healed to a new ulcer occurred at the same location
Measured: 112 days
Recurrent rate
The incidence of ulcer recurrence at each visit.
Measured: 112 days
Changes in wound status
Changes in wound status by Pressure Ulcer Scale for Healing (PUSH) tool
Measured: 112 days
Change in pain score of the target lesion from baseline
Change in pain score of the target lesion from baseline by using the Visual Analog Scale (VAS)
Measured: 112 days
The Quality of Life
The Quality of Life by using the Short Form (SF)-36 Health Survey
Measured: 112 days
Laboratory data changes
Biochemistry, Hematology, Urinalysis
Measured: 112 days
AE incidences over the study period
AE recording
Measured: 112 days
Incidence of treatment related AE with ≥ Grade 2
Incidence of subjects experiencing treatment related AE with ≥ Grade 2 according to the predefined toxicity grading scale in this study
Measured: 112 days
Changes in physical examinations
Changes in physical examinations
Measured: 112 days
Changes in vital signs
Changes in vital signs
Measured: 112 days
Changes of ECG examination results
Changes of ECG examination results
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo group 2.5 % GM-XANTHO of cohort A 5 % GM-XANTHO of cohort B.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xantho Biotechnology Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ken Hung, Ph.D., Study director, Virginia Contract Research Organization Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199077
- Sponsor's protocol ID
- XANGMXH20210702
- Status last verified
- Aug 2025
- First submitted
- 27 Dec 2021
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO in Pressure Ulcer Patients
- ClinicalTrials.gov ID
- NCT05199077
- Acronym / sponsor ID
- XANGMXH20210702
- Conditions
- Pressure Ulcer, Diabetes Mellitus
- Keywords
- Pressure Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Xantho Biotechnology Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Virginia Contract Research Organization Co., Ltd.
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 20 Jan 2022 (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.
This is a randomized, placebo-controlled, double-blind, 3-arm, single-center, phase IIa, parallel study to assess the efficacy, safety, and tolerability of topically applied 2.5%, 5% GM-XANTHO plus standard of care in patients with stage II or stage III pressure ulcer.
Detailed description
This is a randomized, placebo-controlled, double-blind,three-arm, single-centered, parallel study to evaluate the efficacy and safety profiles of the topical ointment, GM-XANTHO. For placebo group and cohort A, at least 30% eligible subjects with DM will be enrolled, for cohort B, only eligible subjects with DM will be enrolled.
Patients with pressure ulcer will be instructed to apply appropriate amount of placebo ( 3.2 mg/cm 2, for placebo group) 2.5 % GM-XANTHO [3.2 mg/cm 2, for cohort A ], or 5% GM-XANTHO [3.2 mg/cm 2, for cohort B] ointment once a day for 28 days. The appropriate dressings that maintain a moist wound as a standard background intervention.
For primary endpoint, the wound completed healing rate of the target lesion will be continuously observed to evaluate the efficacy. For secondary endpoints, the efficacy profile of GM-XANTHO will be assessed by the healing time, recurrent time and recurrent rate. The baseline of each efficacy factors will be evaluated on Day 1 before dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- placebo group 2.5 % GM-XANTHO of cohort A 5 % GM-XANTHO of cohort B.
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: GM-XANTHOTopical administration of a drug-free placebo ointment daily for 28 days. |
| cohort A | Active comparator | Drug: GM-XANTHOTopical administration of a 2.5 % GM-XANTHO ointment daily for 28 days. |
| cohort B | Active comparator | Drug: GM-XANTHOTopical administration of a 5 % GM-XANTHO ointment daily for 28 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 1. Female or male inpatients including in those staying in a long-term care facility, age ≥ 20 years old.
- 2. Patient who is able to understand the nature of this study and accepts to enter the study by signing written informed consent.
- 3. Patient is willing to comply with protocol-stated requirements, instructions and restrictions.
- 4. Patients who have at least 1 well diagnosed Stage 2 to 3 friction-injury associated PU (according to National Pressure Ulcer Advisory Panel [NPUAP] Staging Guidelines, 2019) as the index ulcer at Screening Visit and First Dosing Visit located in any of the following regions.
- 5. Surface dimensions of the index PU should be ≥ 5 cm2 and ≤ 50 cm2 as measured by the greatest length and width method through using an mm-scale ruler.
Key exclusion criteria (6 listed)
- 1. Surgical treatment of pressure ulcers within 30 days prior to the Screening Visit.
- 2. Patients who have any concurrent skin condition that will interfere with assessment of treatment or any condition associated with a wound healing abnormality (e.g.: connective tissue disorder or immune disorder).
- 3. Patients who have active infection on the PU site(s) at baseline 4. Patients who have known hypersensitivity to the study medication 5. Patients with chronic condition(s) which either is not stable or not well controlled.
- 6. Patients having positive results for HBV, HCV or HIV screens 7. Patients who are pregnant or breast feeding 8. Patients carry history of malignancy of any organ system (other than cervical carcinoma in situ or localized prostate cancer) within 5 years prior to study entry.
- 9. Patients had participated in investigational drug trials and took any investigational drugs within 30 days or within 5 half-life of the investigational drugs prior to the screening visit.
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 |
|---|---|---|
| GM-XANTHOAlso: Placeboa topical applied ointment | Drug | cohort A, cohort B, placebo group |
Primary outcome
percentage change
Time frame: 112 days
percentage change in ulcer area
13 secondary outcomes
Time to complete wound closure
Time frame: 112 days
The incidence of complete wound closure of the target lesion.
Time frame: 112 days
Time to Recurrence
Time frame: 112 days
Recurrent rate
Time frame: 112 days
Changes in wound status
Time frame: 112 days
Change in pain score of the target lesion from baseline
Time frame: 112 days
The Quality of Life
Time frame: 112 days
Laboratory data changes
Time frame: 112 days
AE incidences over the study period
Time frame: 112 days
Incidence of treatment related AE with ≥ Grade 2
Time frame: 112 days
Changes in physical examinations
Time frame: 112 days
Changes in vital signs
Time frame: 112 days
Changes of ECG examination results
Time frame: 112 days
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 3 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Pressure Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
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.
Ken Hung, Ph.D. study director
Virginia Contract Research Organization Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-XANTHO in people with Pressure Ulcer and Diabetes Mellitus, run by Xantho Biotechnology Co., LTD at 1 site in Taiwan.
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 22 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Sep 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Echo Lee, Master (+886-2-26575399 ext. 4218, echo.lee@vcro.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage change (time frame: 112 days). 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 3 Sep 2025.