Chronic Refractory Wounds (Diabetic Foot Ulcer, Venous Ulceration, Pressure Injury)
Conditions
Interventions
Experimental group:Biological/Vaccine: Collagenase Ointment
Usage:
Debridement method: The peri wound area will be disinfected with 0.5% iodophor first, then debridement will be carried out base on a
Controlled group:Biological/Vaccine: Hydrogel Dressings
Usage:
Debridement method: The peri wound area will be disinfected with 0.5% iodophor first, then debridement will be carried out base on assess
Sponsors
The Fourth Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participants, either men or women are between 18 to 75 years of age; 2. chronic refractory wounds that meet one of the following requirements: a) Diagnostic criteria for diabetic foot, Wagner grade 2-3 and ABI in the range of 0.7 to 1.3; b) Patients with C5 (healed ulcers on the skin) or C6 (active ulcers on the skin) ulcers according to the 2020 CEAP classification of the Venous Ulcer Classification Criteria, and ABI in the range of 0.7 to 1.3; c) Patients with diagnosis of pressure injury stage II and III according to the 2016 National Pressure Ulcer Advisory Board; 3. Target wound surface area in the range of 5cm2 to 50cm2, if there is more than one wound, select the latest wound as the target test site; 4. Patients with fast glucose test results in the range of 4.4mmol/L to 10mmol/L; 5. At least 20% of the wound is covered by necrotic tissue; 6. Voluntarily participate in the study and be able to complete the study and follow-up according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients have contraindications or allergies to the study drug or its components; 2. Comorbidities that affect the healing of the skin (skin diseases, autoimmune diseases); 3. Patients with cardiac disease, or liver, kidney, and other important organ lesions [NYHA grade = grade 3, alanine or aspartate aminotransferase >2.5 times the upper limit of normal, albumin 1.5 times the upper limit of normal)]; 4. Patients with severe anemia, hemoglobin 38°C or 90 beats/min; (3) respiratory rate> 20 beats/min; (4) altered consciousness; (5) white blood cell count> 12×109/L or 10%]; 7. Patients with arterial and venous thrombosis or varicose veins of the lower extremities that have not been effectively treated; 8. Pregnant, breast-feeding or planning for pregnancy during the clinical trial; 9. Received systemic treatment with hormones, chemotherapy, immunosuppressive drugs, and other drugs within the past 1 month; 10. Patients used drugs that promote healing such as growth factors in the past 2 weeks; 11. Participation in other clinical studies within 3 months prior to enrollment; 12. Poor compliance or any other subject who is not suitable to participate in this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of the wound area changed at 8-week compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average wound healing time;Granulation growth;Time to complete clearance of wound necrotic tissue;Wound healing rate; | — |
Countries
CHINA
Contacts
Public ContactCHUANAN SHEN
The Fourth Medical Center of PLA General Hospital
Outcome results
None listed