Diabetic foot ulcer
Conditions
Interventions
Low dose RGL-2102 Group:Topical RGL-2102 20 µ g/mL, BiW
High dose RGL-2102 Group:Topical RGL-2102 60 µ g/mL, BiW
Placebo group:Spray sodium chloride injection for external use, BiW
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all? of the following criteria to be enrolled in this study: 1. Age >=18 years and =0.6 and =30 mmHg. 5. Adequate organ and bone marrow function, meeting the following laboratory test results within a specified period before the first dose: 1) Hemoglobin (Hb) >= 80 g/L; 2) Albumin (Alb) >= 30 g/L; 3) Platelet count (PLT) >= 100 × 10?/L; 4) White blood cell count (WBC) >= 3.0 × 10?/L and = 12.0 × 10?/L; 5) Alanine aminotransferase (ALT) <= 3 × ULN (Upper Limit of Normal); Aspartate aminotransferase (AST) <= 3 × ULN; 6) Serum creatinine (Cr) <= 2 × ULN; 7) Fasting blood glucose <= 10 mmol/L; 8) Coagulation profile: International Normalized Ratio (INR) <= 1.5 × ULN; Activated Partial Thromboplastin Time (APTT) <= 1.5 × ULN. 6. Ability to understand the study procedures and methods, voluntary agreement to participate in the trial, and provision of written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any? of the following criteria will be excluded from the study: 1. The target wound presents with gangrene, suppuration, or sinus tracts that cannot be removed by debridement; or has active osteomyelitis, cellulitis, etc.; or has exposed tendon or bone; or has potential for malignancy. 2. Active or chronic Charcot foot in the limb with the target wound. 3. Use of topical cell/growth factor therapies, immunosuppressants, or other medications that affect wound healing on the target wound. Or, systemic use of immunosuppressants (including corticosteroids), cytotoxic chemotherapy, cytostatic therapy, or treatments for autoimmune diseases within 1 month prior to screening. 4. History or presence of the following diseases or treatments: 1) Proliferative diabetic retinopathy or other proliferative retinal diseases, or inability to undergo retinal examination (except for those with treated/controlled and stable proliferative retinopathy at screening, in the investigator's judgment). 2) History of malignant tumors within the past 5 years, except for cured localized cancers such as basal cell carcinoma of the skin, thyroid cancer, etc. 3) Previous treatment with gene or cell therapy (including plasmid DNA, genetically modified viruses, bacteria or cells, and gene-editing-based products) or participation in gene/cell therapy-related clinical trials. 4) Participation in other investigational drug clinical trials within 30 days prior to screening (except for screen failures), or still within 5 half-lives of the investigational drug at the time of randomization (whichever is longer). 5) Cardiac function classified as New York Heart Association (NYHA) Class III or IV at screening or randomization. 6) History of connective tissue disease or autoimmune disease affecting wound healing, including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, etc. 7) Refractory hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg after adequate antihypertensive therapy). 8) Acute diabetic complications within 30 days prior to screening, or acute cardio/cerebrovascular events within 90 days prior to screening, including but not limited to diabetic ketoacidosis, cerebral infarction (except lacunar infarction), cerebral hemorrhage, myocardial infarction, unstable angina, severe arrhythmia, etc. 9) Surgery within 30 days prior to screening, or planned surgery during the study period, that would interfere with wound assessment (excluding toe amputation, debridement, etc.). 10) Suspected history of allergy to the investigational product or any of its components. 11) History of drug abuse or substance abuse. 12) Known infection with Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV) infection, active Hepatitis C Virus (HCV) infection, active tuberculosis, syphilis, or other infectious diseases deemed by the investigator as unsuitable for trial participation. a) Active HBV infection: Positive Hepatitis B surface antigen (HBsAg) at screening AND HBV-DNA viral load above the upper limit of the normal reference range of the local institution. b) Active HCV infection: Positive for both HCV antibody and HCV-RNA test results at screening. 13) Positive pregnancy test. 5. General Conditions: 1) Inability to accurately describe symptoms or feelings. 2) Unwillingness to use highly effective contraception during the study and for 6 months after the last dose (for both male and female subjects of childbear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of wounds with complete healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to complete wound healing;The proportion of wounds with complete healing at all visits ;Change in wound area from baseline at each visit;The proportion of patients achieving =50% and =75% reduction in wound area from baseline at each visit ;Change from baseline in wound pain Numerical Rating Scale (NRS) score;Change from baseline in the Diabetic Foot Ulcer Scale - Short Form (DFS-SF) score; | — |
Countries
China
Contacts
Public ContactXingwu Ran
West China Hospital, Sichuan University?
Outcome results
None listed