A Study of GM-XANTHO in Pressure Ulcer Patients
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorXantho Biotechnology Co., LTD
About this trial
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.
Eligibility criteria
Qualifiers
1. Female or male inpatients including in those staying in a long-term care facility, age ≥ 20 years old.
Hemoglobin ≥ 10 g/dL
Total WBC ≥ 3,000 cells/μL
Platelet ≥ 55,000 counts/μL without transfusion support
Disqualifiers
1. Surgical treatment of pressure ulcers within 30 days prior to the Screening Visit.
Trial design
Treatments tested in this trial
- GM-XANTHO
Treatment groups
58 Participants
are divided into 3 treatment groupsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
National Taiwan University Hospital Status unavailable 100225, Taipei, Taipei
Taiwan
TaiwanSponsors and collaborators
Xantho Biotechnology Co., LTD
Lead sponsor
Virginia Contract Research Organization Co., Ltd.
Collaborator
Source ClinicalTrials.gov