diabetic foot
Conditions
Interventions
experimental group:external application of Nr-CWS
control group:silver-contained wound dressings
Sponsors
Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old (including 18 and 80 years old); 2. Type 2 diabetic foot patients, in line with the 1999 WHO diagnostic criteria for diabetic foot, and the glycated hemoglobin (HbA1C) detected within the screening period or within three months before randomization is less than 10%; 3. The ankle-brachial index of the target limb is at least 0.8, and there is no intermittent claudication; 4. The target ulcer must have the following characteristics: (1) Grade 1 or 2 according to the Wagner ulcer grading system; (2) Ulcers are located on the foot, ankle and anterior tibia; (3) The wound area is 2-5cm2; (4) At least 4 weeks prior to randomization; (5) If there are multiple wounds, select the one that meets the inclusion criteria and has the largest area for intervention and evaluation. Routine treatment of other wounds was not included in the study; if two or more wounds were the largest, the one with the most severe grade was selected for inclusion; if two or more wounds had the same area and grade, the one with the longest duration of wound area was selected for inclusion in the study ; (6) No pus and necrotic material visible to the naked eye; 5. Voluntarily participate in this clinical study, be able to cooperate with doctors to carry out the study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with clear surgical indications, such as vascular occlusion, bone exposure, abscess, osteomyelitis, etc.; 2. Those who have undergone vascular reconstruction surgery or angioplasty within 3 months before enrollment; 3. Patients with impaired liver function (ALT and AST exceed 3 times the upper limit of normal, AST: aspartate aminotransferase; ALT: alanine aminotransferase); 4. Serum creatinine greater than 2 times the upper limit of normal; 5. Serum albumin <2.0 g/dL; 6. Those who are undergoing immunosuppressive drug treatment; 7. Patients with various malignant tumors; 8. Pregnant women, breastfeeding women or those who have a childbearing plan in the near future; 9. Those who are unable to cooperate or are unwilling to cooperate with combined neurological and mental disorders, those who have a history of alcoholism and drug abuse, and those who have not been able to effectively quit; 10. Those who have participated in other clinical trials within 3 months before enrollment; 11. Those who have contraindications, allergies or known allergies to the use of Nocardia erythraea cell wall skeleton or silver-containing products; 12. Other situations in which the patient is considered unsuitable to participate in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-days wound healing rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| healing time;Complete healing rate;Surgical intervention rate;Pathogenic bacteria positive rate; | — |
Countries
China
Contacts
Public ContactJin Peisheng
Plastic Surgery Center, Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed