A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO in Pressure Ulcer Patients
Overview
- Phase
- Phase 2
- Intervention
- GM-XANTHO
- Conditions
- Pressure Ulcer
- Sponsor
- Xantho Biotechnology Co., LTD
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- percentage change
- Status
- Not yet recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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)
- •Patients who agree discontinuation of systemic corticosteroids and systemic immune modulating agents during the study period
- •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:
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
- •Patients who have known hypersensitivity to the study medication
- •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
- •Patients who are pregnant or breast feeding
- •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)
Arms & Interventions
placebo group
Topical administration of a drug-free placebo ointment daily for 28 days.
Intervention: GM-XANTHO
cohort A
Topical administration of a 2.5 % GM-XANTHO ointment daily for 28 days.
Intervention: GM-XANTHO
cohort B
Topical administration of a 5 % GM-XANTHO ointment daily for 28 days.
Intervention: GM-XANTHO
Outcomes
Primary Outcomes
percentage change
Time Frame: 112 days
percentage change in ulcer area
Secondary Outcomes
- 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 vital signs(112 days)
- Changes in wound status(112 days)
- Change in pain score of the target lesion from baseline(112 days)
- The Quality of Life(112 days)
- Laboratory data changes(112 days)
- Changes of ECG examination results(112 days)
- AE incidences over the study period(112 days)
- Changes in physical examinations(112 days)
- Incidence of treatment related AE with ≥ Grade 2(112 days)