A Study of GM-XANTHO in Pressure Ulcer Patients

NCT05199077 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: XANGMXH20210702
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer; Diabetes Mellitus

Keywords

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• percentage change

  percentage change in ulcer area

  112 days

Secondary Outcomes (13)

• Time to complete wound closure

  112 days

• The incidence of complete wound closure of the target lesion.

  112 days

• Time to Recurrence

  112 days

• Recurrent rate

  112 days

• Changes in wound status

  112 days

Study Arms (3)

placebo group

PLACEBO COMPARATOR

Topical administration of a drug-free placebo ointment daily for 28 days.

Drug: GM-XANTHO

cohort A

ACTIVE COMPARATOR

Topical administration of a 2.5 % GM-XANTHO ointment daily for 28 days.

Drug: GM-XANTHO

cohort B

ACTIVE COMPARATOR

Topical administration of a 5 % GM-XANTHO ointment daily for 28 days.

Drug: GM-XANTHO

Interventions

GM-XANTHO DRUG

a topical applied ointment

Also known as: Placebo

cohort A; cohort B; placebo group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Female or male inpatients including in those staying in a long-term care facility, age ≥ 20 years old.
• \. Patient who is able to understand the nature of this study and accepts to enter the study by signing written informed consent.
• \. Patient is willing to comply with protocol-stated requirements, instructions and restrictions.
• \. 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.
• \. 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.
• \. 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.
• \. 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).
• \. 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.

You may not qualify if:

• \. Surgical treatment of pressure ulcers within 30 days prior to the Screening Visit.
• \. 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).
• \. 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.
• \. 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.
• \. 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.
• \. Patients who are not suitable to participate in the trial as judged by the Investigator(s)

Sponsors & Collaborators

• Xantho Biotechnology Co., LTD: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100225, Taiwan

Location

MeSH Terms

Conditions

Pressure Ulcer; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ken Hung, Ph.D.

  Virginia Contract Research Organization Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Echo Lee, Master

CONTACT

+886-2-26575399; echo.lee@vcro.com.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: placebo group 2.5 % GM-XANTHO of cohort A 5 % GM-XANTHO of cohort B.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 20, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)