diabetic foot
Conditions
Interventions
Experimental group:recombinant human collagen hydrogel
Control group:standard of care (SOC)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. No gender limit, aged between 18 and 80 years; 2. Target wound surface <=10cm^2; 3. Patients whose wound was clinically diagnosed as diabetic foot disease, whose necrotic tissue had been basically cleared, and who still needed dressing change for more than 3 weeks after being confirmed by clinicians; 4. Wagner rated grade 1 or 2; 5. Those who agree to participate in the study and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Severe malnutrition, albumin 38.5? or white blood cells >12*10^9/L or redness and swelling of wound edge >5cm; 3. Multi-drug resistant bacterial infection or systemic severe infection that is difficult to control; 4. The patient has a history of allergy to the ingredients contained in this product and the control product or is allergic to two or more allergens; 5. Chronic skin ulcers or other causes of body surface ulcers and sinus tract; 6. Participated in other clinical researchers within 1 month before the admission; 7. Patients with other conditions that researchers consider inappropriate to participate in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficiency;Wound reduction rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events; | — |
Countries
China
Contacts
Public ContactLu Bin
Huashan Hospital, Fudan University
Outcome results
None listed