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Clinical 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05199077
Study type Interventional
Source Xantho Biotechnology Co., LTD
Contact Echo Lee, Master
Phone +886-2-26575399
Email echo.lee@vcro.com.tw
Status Not yet recruiting
Phase Phase 2
Start date July 1, 2024
Completion date June 30, 2026

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