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 range20 Years – 80 Years
SexALL
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)
✓. Ulcer is located on or below the malleoli.
✓. 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
What they're measuring
1
Incidence of treatment-related Adverse Events associated with Fespixon cream
✕. 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: