Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diab… (NCT06531512) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
China120 participantsStarted 2024-08-16
Plain-language summary
This is a phase II/III seamless design, randomized, double-blind, paralleled-group, placebo-controlled study to evaluate the efficacy and safety of Xianglei Tangzu Gao for the treatment of Wagner grade II diabetic foot ulcers. The primary endpoint is the proportion of subjects with complete closure of target ulcer during the 16-week treatment phase.
Who can participate
Age range
18 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 18 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%.
. Diagnosis with Diabetic Peripheral Neuropathy (DPN) or vascular disease defined by Chinese guidelines for diagnosis and treatment of diabetic foot (2020 version). Subject has adequate vascular perfusion of the affected limb, no obvious clinical manifestations of lower limb ischemia, confirmed by Ankle-Brachial Index (ABI) ≥ 0.8 and ≤ 1.3, or transcutaneous pressure of oxygen (TcPO2) \> 30 mmHg on at least one lead.
. An ulcer of Wagner Grade II.
. Presence of at least one diabetic foot ulcer that meets all of the following criteria:
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
The proportion of subjects with complete closure of Target Ulcer
. Ulcer size (area) is \> 1 cm2 and ≤ 25 cm2 (post-debridement at time of screening and randomization)
. Ulcer is located on or below the malleoli and presents duration of between 4 weeks and 12 months (at time of screening).
. If there are more than two ulcers, there should be a minimum 3 cm margin between the qualifying Target Ulcer and any other ulcers on the specified foot (post- debridement).
Exclusion criteria
. In response to the standard of care, ulcer size reduction is \> 30% during the two-week run-in Screening Period (between the first Screening Visit/V0 and Baseline/V2 randomization).
. Ulcers with exposed bone or associated with osteomyelitis. Note: The osteomyelitis should be ruled out by clinical examination (probing of the wound) and X-ray findings.
. Presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement.
. Laboratory values at Screening of:
. White Blood Cells (WBC) \< 3.0 X 109 cells/L, \> 12.0 X 109 cells/L
. C-Reactive Protein (CRP) \>100 mg/L
. Liver function studies \[Total bilirubin, aspartate aminotransferase (AST) and alanine transaminase (ALT)\] \> 3x the upper limit of normal