Clinical trial NCT05317442: Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Official title: Open-label Study to Evaluate the Efficacy and Safety of Fespixon Cream for the Treatment of Pressure Injury in Sacrum and Greater Trochanter Wound
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pressure Injury Stage 2
Keywords: Fespixon
Pressure Injury
Wound
NPIAP Stage 2
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
Collaborators: name: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Oneness Biotech Co., Ltd.
First posted: 2022-04-07
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 1. Uncontrolled
2. Open-label
3. Randomized: N/A
4. Single Arm
5. Duration of treatment: up to 16 weeks
6. Titration: no
7. Multi-center(Taiwan)
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 1. Main inclusion criteria:

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

2. Main exclusion criteria:

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

Primary outcomes:
measure: Incidence of treatment-related Adverse Events associated with Fespixon cream
timeFrame: 16 weeks
Secondary outcomes:
measure: Incidence of complete wound closure of the target ulcer area
timeFrame: 16 weeks
measure: Time to complete wound closure of the target ulcer area
timeFrame: 16 weeks
measure: Percentage of target ulcer wound area reduction at visit 9/ EOT (changed from V1 baseline)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Municipal Ta-Tung Hospital（Managed by Kaohsiung Medical University Chung-Ho Memorial Hospital）
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University WanFang Hospital
Study officials:
affiliation: Taipei Medical University WanFang Hospital
name: Hsian-Jenn Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Shu-Hung Huang
role: PRINCIPAL_INVESTIGATOR
References: