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A Study of GM-XANTHO in Pressure Ulcer Patients

ConditionsPressure UlcerDiabetes Mellitus
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • GM-XANTHO

    Drug

    a topical applied ointment

Treatment groups

58 Participants
are divided into 3 treatment groups
Group A: placebo groupPlacebo comparator 1 intervention
Group B: cohort AActive comparator 1 intervention
Group C: cohort BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

percentage change

percentage change in ulcer area

Time frame
112 days

Secondary outcomes

1

Time to complete wound closure

The time from the baseline to the complete healing of the target lesion

Time frame
112 days
2

The incidence of complete wound closure of the target lesion.

The percentage of subjects that achieved complete wound closure from baseline at each visit.

Time frame
112 days
3

Time to Recurrence

The time from when the target lesion is completely healed to a new ulcer occurred at the same location

Time frame
112 days
4

Recurrent rate

The incidence of ulcer recurrence at each visit.

Time frame
112 days

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

National Taiwan University Hospital Status unavailable 100225, Taipei, TaipeiTaiwanTaiwan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xantho Biotechnology Co., LTD

Lead sponsor

Virginia Contract Research Organization Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: