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A Study of GM-XANTHO in Pressure Ulcer Patients

Primary Purpose

Pressure Ulcer, Diabetes Mellitus

Status
Not yet recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
GM-XANTHO
Sponsored by
Xantho Biotechnology Co., LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer focused on measuring Pressure Ulcer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

    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.

    1. 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].
    2. 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.
    3. Male sterilization. For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
    4. 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.

Exclusion Criteria:

  • 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)

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo group

cohort A

cohort B

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

percentage change
percentage change in ulcer area

Secondary Outcome Measures

Time to complete wound closure
The time from the baseline to the complete healing of the target lesion
The incidence of complete wound closure of the target lesion.
The percentage of subjects that achieved complete wound closure from baseline at each visit.
Time to Recurrence
The time from when the target lesion is completely healed to a new ulcer occurred at the same location
Recurrent rate
The incidence of ulcer recurrence at each visit.
Changes in wound status
Changes in wound status by Pressure Ulcer Scale for Healing (PUSH) tool
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)
The Quality of Life
The Quality of Life by using the Short Form (SF)-36 Health Survey
Laboratory data changes
Biochemistry, Hematology, Urinalysis
AE incidences over the study period
AE recording
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
Changes in physical examinations
Changes in physical examinations
Changes in vital signs
Changes in vital signs
Changes of ECG examination results
Changes of ECG examination results

Full Information

First Posted
December 27, 2021
Last Updated
July 12, 2023
Sponsor
Xantho Biotechnology Co., LTD
Collaborators
Virginia Contract Research Organization Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05199077
Brief Title
A Study of GM-XANTHO in Pressure Ulcer Patients
Official Title
A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO in Pressure Ulcer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xantho Biotechnology Co., LTD
Collaborators
Virginia Contract Research Organization Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Diabetes Mellitus
Keywords
Pressure Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
placebo group 2.5 % GM-XANTHO of cohort A 5 % GM-XANTHO of cohort B.
Masking
ParticipantInvestigator
Masking Description
Double blinded
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Topical administration of a drug-free placebo ointment daily for 28 days.
Arm Title
cohort A
Arm Type
Active Comparator
Arm Description
Topical administration of a 2.5 % GM-XANTHO ointment daily for 28 days.
Arm Title
cohort B
Arm Type
Active Comparator
Arm Description
Topical administration of a 5 % GM-XANTHO ointment daily for 28 days.
Intervention Type
Drug
Intervention Name(s)
GM-XANTHO
Other Intervention Name(s)
Placebo
Intervention Description
a topical applied ointment
Primary Outcome Measure Information:
Title
percentage change
Description
percentage change in ulcer area
Time Frame
112 days
Secondary Outcome Measure Information:
Title
Time to complete wound closure
Description
The time from the baseline to the complete healing of the target lesion
Time Frame
112 days
Title
The incidence of complete wound closure of the target lesion.
Description
The percentage of subjects that achieved complete wound closure from baseline at each visit.
Time Frame
112 days
Title
Time to Recurrence
Description
The time from when the target lesion is completely healed to a new ulcer occurred at the same location
Time Frame
112 days
Title
Recurrent rate
Description
The incidence of ulcer recurrence at each visit.
Time Frame
112 days
Title
Changes in wound status
Description
Changes in wound status by Pressure Ulcer Scale for Healing (PUSH) tool
Time Frame
112 days
Title
Change in pain score of the target lesion from baseline
Description
Change in pain score of the target lesion from baseline by using the Visual Analog Scale (VAS)
Time Frame
112 days
Title
The Quality of Life
Description
The Quality of Life by using the Short Form (SF)-36 Health Survey
Time Frame
112 days
Title
Laboratory data changes
Description
Biochemistry, Hematology, Urinalysis
Time Frame
112 days
Title
AE incidences over the study period
Description
AE recording
Time Frame
112 days
Title
Incidence of treatment related AE with ≥ Grade 2
Description
Incidence of subjects experiencing treatment related AE with ≥ Grade 2 according to the predefined toxicity grading scale in this study
Time Frame
112 days
Title
Changes in physical examinations
Description
Changes in physical examinations
Time Frame
112 days
Title
Changes in vital signs
Description
Changes in vital signs
Time Frame
112 days
Title
Changes of ECG examination results
Description
Changes of ECG examination results
Time Frame
112 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Echo Lee, Master
Phone
+886-2-26575399
Ext
4218
Email
echo.lee@vcro.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Hung, Ph.D.
Organizational Affiliation
Virginia Contract Research Organization Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100225
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study of GM-XANTHO in Pressure Ulcer Patients

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