diabetic limb vascular disease
Conditions
Interventions
standard care group (Group A):Standard Care + Placebo Group: Following routine surgical debridement, the wound will be cleansed with normal saline. The placebo ointment will then be applied topically,
Jing Wan Hong Ointment Group (Group B):Standard Care + Jing Wan Hong Ointment Group (Group B): Following routine surgical debridement, the wound will be cleansed with normal saline. Jing Wan Hong Oint
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis conforms to the Western medical diagnostic criteria for Type 2 Diabetes Mellitus. 2. Fasting venous blood glucose level is <= 10 mmol/L. 3. Age between 65 years (inclusive) and 80 years (inclusive); gender-matched. 4. Ulcer depth extends to the skin and subcutaneous tissue, without involvement of muscle, tendons, or bone; no significant infection present or infection is controlled after debridement. 5. Skin defect area of the ulcer is between 1 cm² and 8 cm² after debridement. 6. Does not meet the criteria requiring surgical intervention. 7. The subject agrees to participate and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of severe food and/or drug allergies. 2. Diabetic limb vascular lesions requiring surgical treatment. 3. Comorbid with severe cardiac, cerebral, hepatic, or hematopoietic system diseases, or other severe diseases affecting survival. 4. Skin ulcers caused by electrical, chemical, radioactive, or other etiologies; OR presence of malignant changes at the ulcer site; OR the target ulcer area after debridement is 8 cm². 5. Exposure to radiation or use of hormonal therapy, chemotherapy, growth factor-based dressings, or immunosuppressants within the past 3 months. 6. Ankle-Brachial Index (ABI) of the affected limb is 1.3. 7. Current presence of significant infection at the ulcer wound site. 8. Presence of necrotic bone or infected bone at the ulcer base that has not been surgically debrided. 9. Venous stasis ulcers (or Varicose ulcers). 10. Hemoglobin = 180/110 mmHg. 12. Pregnancy or lactation. 13. Severe cardiac or hepatic dysfunction (Cardiac function NYHA Class >= III, Child-Pugh Class C). 14. Patients with cancer; patients with psychiatric disorders or Alzheimer's disease. 15. Participation in another clinical drug trial within the past 3 months or current participation in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of ulcer surface healing; | — |
Secondary
| Measure | Time frame |
|---|---|
| SINBAD score; | — |
Countries
China
Contacts
Public ContactMin Zhang
Beijing Chaoyang Hospital, Capital Medical University
Outcome results
None listed