A Study of GM-XANTHO in Pressure Ulcer Patients

Sponsor
Xantho Biotechnology Co., LTD
Study ID
NCT05199077
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus
  • Pressure Ulcer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GM-XANTHO — DRUG
    a topical applied ointment

Study Details

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.

Key Dates

First listed
Jan 20, 2022
Start date
Sep 1, 2026
Status verified
Aug 2025
Primary completion
Dec 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
58 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo group
    Topical administration of a drug-free placebo ointment daily for 28 days.
  • Active Comparator: cohort A
    Topical administration of a 2.5 % GM-XANTHO ointment daily for 28 days.
  • Active Comparator: cohort B
    Topical administration of a 5 % GM-XANTHO ointment daily for 28 days.

Primary Outcome Measure

percentage change [ Time Frame: 112 days ]

Central Contacts

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