A Study of GM-XANTHO in Pressure Ulcer Patients
NCT05199077 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2025-09-03
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
Interventions
- DRUG
-
GM-XANTHO
a topical applied ointment
Sponsors & Collaborators
-
Virginia Contract Research Organization Co., Ltd.
collaborator OTHER -
Xantho Biotechnology Co., LTD
lead INDUSTRY
Principal Investigators
-
Ken Hung, Ph.D. · Virginia Contract Research Organization Co., Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-04-30
- FDA Drug
- Yes
Countries
- Taiwan
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