A Study of GM-XANTHO in Pressure Ulcer Patients
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.
official title
A Phase IIa Study to Investigate the Efficacy and Safety Profile of GM-XANTHO in Pressure Ulcer Patients