Diabetic osteoarthritis
Conditions
Interventions
Trial group:Administer 2ml of Sifera by intra-articular injection, once every 2 weeks, for a total of 5 times (a total of 10 weeks)
Control group:Receive an equal amount of hyaluronic acid injection into the joint cavity, also once every two weeks, for a total of five times.
Sponsors
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 45 years and = 7.0 mmol/L, 2-hour post-meal or oral glucose tolerance test (OGTT) blood glucose >= 11.1 mmol/L, random blood glucose >= 11.1 mmol/L; 3. Meets the diagnostic criteria of the American College of Rheumatology for knee osteoarthritis, with Kellgren-Lawrence grade II-III, or MRI showing subchondral bone marrow edema, joint effusion, etc.; 4. Experienced knee joint pain for most days in the past month, with VAS score >= 4 points. 5.Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Within the past 6 months, have received intra-articular injection therapy (including hormones, hyaluronic acid, etc.) or undergone knee joint surgery; 2. Severe knee joint deformity (varus > 5° or valgus > 5°); 3. Complicated with inflammatory joint diseases such as rheumatoid arthritis, psoriatic arthritis, gout, etc.; 4. Severe coagulation dysfunction or currently using anticoagulant drugs; 5. Within the past 1 week, have used non-steroidal anti-inflammatory drugs or analgesics (except acetaminophen); 6. Poor blood sugar control (HbA1c > 10%) or have acute complications such as diabetic ketoacidosis; 7. Severe heart, liver, or kidney dysfunction; 8. Known to be allergic to any component of Seifei; 9. Pregnant or lactating women; 10. Currently participating in other clinical trials; 11. Have a history of malignant tumors or are currently receiving anti-tumor treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS score;Lysholm Knee Joint Score;Joint bone marrow edema (BME);Biological marker changes and safety; | — |
Countries
China
Contacts
Public ContactQiao Jie
The Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed