Actively Recruiting
Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
Led by Oneness Biotech Co., Ltd. · Updated on 2025-07-02
120
Participants Needed
16
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluate the Efficacy and Safety of Xianglei Tangzu Gao for the Treatment of Wagner Grade II Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 to 80 years with type 1 or type 2 diabetes treated for glycemic control
- Glycosylated hemoglobin (HbA1c) of 12% or less
- Diagnosis of diabetic peripheral neuropathy or vascular disease with adequate blood flow to the affected limb, confirmed by Ankle-Brachial Index between 0.8 and 1.3 or transcutaneous oxygen pressure above 30 mmHg
- Presence of a Wagner grade II diabetic foot ulcer
- At least one diabetic foot ulcer larger than 1 cm2 and up to 25 cm2 after cleaning, located on or below the ankle, lasting between 4 weeks and 12 months
- If more than two ulcers, at least 3 cm distance between the target ulcer and others on the same foot
- No active infection in the ulcer according to clinical criteria
- Negative pregnancy test for women of childbearing potential and use of two medically accepted contraception methods during the study
- Ability to walk and stand on the foot without the target ulcer
- Willingness to use an off-loading device on the ulcer while walking
- Ability and willingness to follow study procedures and dressing changes
- Signed informed consent obtained before study procedures
You will not qualify if you...
- Ulcer size reduced by more than 30% during a two-week screening period
- Ulcers with exposed bone or osteomyelitis confirmed by clinical exam and X-ray
- Presence of necrosis, pus, or sinus tracts that cannot be removed by cleaning
- Abnormal laboratory values including very low or high white blood cells, high C-reactive protein, liver or kidney function tests above three times normal, low albumin, or low hemoglobin
- Medical conditions that could affect wound healing, such as unstable Charcot foot, current sepsis, active cancer, AIDS/HIV, severe heart or brain conditions
- Use of medications or therapies interfering with wound healing within 30 days before randomization, including immunosuppressants, chemotherapy, wound therapies, dialysis, or growth factors
- Previous use of bioengineered tissue or skin substitutes on the target ulcer
- Inability to comply with off-loading instructions due to standing more than 4 hours daily
- Psychiatric conditions or substance abuse that may affect study compliance
- Any other factors judged by the investigator to compromise participation or follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 16 locations
1
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Actively Recruiting
2
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Actively Recruiting
3
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
4
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Withdrawn
5
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Actively Recruiting
6
Shenyang Seventh People's Hospital (Shenyang Hospital of Integrated Traditional Chinese and Western Medicine)
Shenyang, Liaoning, China
Actively Recruiting
7
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Actively Recruiting
8
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
9
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
10
Nanfang Hospital
Guangzhou, China
Actively Recruiting
11
Southern Medical University Third Hospital
Guangzhou, China
Actively Recruiting
12
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Actively Recruiting
13
Huadong Hospital Affiliated to Fudan University
Shanghai, China
Actively Recruiting
14
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, China
Actively Recruiting
15
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
16
Shanghai TCM Integrated Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jessica Ho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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