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
1National Taiwan University Hospital100225, TaipeiTaipei, Taiwan
Sponsors and collaborators
Xantho Biotechnology Co., LTD
Lead sponsor
Virginia Contract Research Organization Co., Ltd.
Collaborator
Source ClinicalTrials.gov