Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients (NCT05338463) | Clinical Trial Compass
CompletedPhase 4
Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in Dialysis Patients
Taiwan5 participantsStarted 2021-12-01
Plain-language summary
Evaluate the Safety and Efficacy of Fespixon Cream for the Treatment of Chronic Diabetic Foot Ulcers (TEXAS 1A, 2A) in dialysis patients This study aimed to evaluate the effects of a topical cream containing Plectranthus amboinicus and Centella Asiatica when applied topically to diabetic foot ulcers in uremia patients with PAOD.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects, male or female, aged 20 to 80 years (inclusive) with Type 1 or Type 2 diabetes undergoing therapy for glycemic control using available diabetes drugs including insulin.
. Subject has a glycosylated hemoglobin, HbA1c ≤ 12%.
. Subjects maintain regular/stable blood purification treatment of hemodialysis (HD) or peritoneal dialysis (PD) for ≥6 months prior to Visit 0.
. Presence of at least one diabetic foot ulcer that meets all of the following criteria:
. A full-thickness ulcer of UTWCS Grade I-A or II-A
. Ulcer size (area) is \> 1 cm² and ≤ 10 cm² (post-debridement at time of enrollment)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of treatment-related Adverse Events associated with Fespixon cream
. Ulcer presents for \> 4 weeks (at time of enrollment).
Exclusion criteria
. In response to standard of care, ulcer size reduction is \> 30% during the two-week run-in Screening Period (between the first Screening Visit/V0 and Baseline/V1).
. Body mass index (BMI) \> 35 kg/m2
. Laboratory values at Screening of:
. Hemoglobin \< 6.0 g/dL
. White Blood Cells (WBC) \< 3.0 X 103 cells/uL； \> 12.0 X 103 cells/uL
. Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal
. Albumin \< 2.5 g/dL
. Presence of any clinically significant medical condition(s) in medical history during screening period that, in the opinion of the investigator, could interfere with wound healing, including but not limited to the following: