Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound

Last updated: April 29, 2024
Sponsor: Taipei Medical University WanFang Hospital
Overall Status: Terminated

Phase

4

Condition

Pressure Ulcer

Treatment

Fespixon Cream

Clinical Study ID

NCT05317442
ON101CLAS05
  • Ages 20-99
  • All Genders

Study Summary

Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound

Eligibility Criteria

Inclusion

  1. Main inclusion criteria:
  2. At least 20 years old, less than 99 (inclusive) years old, with pressure woundslocated in the sacral vertebrae and greater trochanter
  3. NPUAP is classified as stage 2
  4. No active infection, i.e., IDSA level 1
  5. Ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time ofenrollment)
  6. If an artificial ostomy is not performed, the distance between the target ulcer andthe anus must be greater than 5 cm to prevent contamination

Exclusion

  1. Main exclusion criteria:
  2. Those who have an allergic reaction to the ingredients of this product, includingthose who have been allergic to sulfa drugs, Plectranthus amboinicus, Centellaasiatica or excipients
  3. Acute infection caused by wound ( WBC > 12×10³/uL； or C-Reactive protein (CRP) > 30mg/dL)
  4. Liver and kidney dysfunction ( defined as [AST or ALT] > 3× the upper limit of normal;serum creatinine > 3× the upper limit of normal)
  5. Pregnant or lactating women
  6. Infected with human immunodeficiency virus
  7. Body mass index (BMI) less than 18.5 kg/m²
  8. Unable to cooperate with changing of subject's position
  9. Patients with anemia (Hgb < 7.0 g/dL).
  10. Unable to prevent contaminations such as feces or urinary incontinence
  11. Malnutrition (Albumin< 2.5 g/dL)
  12. Presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer
  13. In the opinion of the investigator, entering this trial may pose a threat to subjectcompliance.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Fespixon Cream
Phase: 4
Study Start date:
April 06, 2022
Estimated Completion Date:
April 19, 2024

Study Description

This study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of Fespixon Cream for the treatment of pressure injury in sacrum wound. The duration of this study is: run in/ screen phase (2 weeks); treatment phase (16 weeks); follow-up phase (4 weeks), and visits are conducted every 2 weeks for a total of 12 visits. During the treatment phase, the Fespixon cream will be applied to the target ulcer once a day for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 4 weeks. During the follow-up phase, standard of care will be used for subjects who have unhealed or with recurrent wounds.

At each visit, the size and changes of the target pressure ulcer are recorded by photographing. The target pressure ulcer area in the photo is calculated using Image Pro® PLUS software.

Connect with a study center

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756
    Taiwan

    Site Not Available

  • Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）

    Kaohsiung City, 801
    Taiwan

    Site Not Available

  • Taipei Medical University WanFang Hospital

    Taipei City, 10675
    Taiwan

    Site Not Available

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