diabetes ulcers
Conditions
Interventions
control group:Placebo+basic treatment+wound management: routine debridement and dressing change
trial group:Zizhu ointment+basic treatment+wound management: routine debridement and dressing change
Sponsors
Shuguang Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Men and women aged 118 to 65 2.Diagnosis record of type 21 or type 2 diabetes 3. Foot ulcer at or below the ankle lasting for >4 weeks to 0.7 TcPO2>30 mmHg skin perfusion>30mmHg toe pressure>30 mmHg 9 Subject and caregiver are willing and able to comply with all specified care and visitation requirements 10. The subjects have reasonable expectations for completing the study
Exclusion criteria
Exclusion criteria: Gangrene occurs in any part of the affected limb. There is documented evidence of osteomyelitis in any part of the affected limb. Renal dialysis or creatinine levels >2.5 mg/dL (221 µmol/L). Use of chronic steroids or immunosuppressants within the past 3 months or anticipation of needing them during the study period. The subject has participated in another clinical drug study within the past 30 days. Patients who are allergic or intolerant to the study medication. Pregnant or lactating women or women at risk of pregnancy. Patients with severe cardiovascular and cerebrovascular diseases digestive system diseases endocrine system diseases neurological diseases etc. Patients with mental illness or depression. Situations deemed unsuitable for participation in this clinical trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of osteomyelitis;TCM Symptom Score of diabetes Foot Ulcer;Wound blood flow;transcutaneous oxygen pressure;Amputation rate;Ulcer recurrence rate (6-week follow-up); | — |
Countries
China
Contacts
Public ContactWeijing Fan
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed