The main inclusion criteria were patients with diabetic foot ulcers and a Wagner classification of 2-3.
Conditions
Interventions
C Group :Standard wound care + decellularized dermal matrix once a week treatment
T2 Group :Standard wound care + decellularized biological amniotic membrane, once every two weeks for treatment
T1 Group :Standard wound care + decellularized biological amniotic membrane treatment once a week
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years old, gender is not limited; 2. Suffering from type I or type II diabetes; 3. The target ulcer is graded as 2-3; 4. After systemic treatment of the wound and standard care treatment of the ulcer, the wound and the wound area are completely clean, there is no purulent discharge, inactivated tissue and signs of active infection on the wound, and healthy red granulation tissue can be seen on the wound bed; 5. Duration of diabetic foot ulcer >=4 weeks; 6. The area size of diabetic foot ulcer is between 0.5-25cm^2; 7. Ankle-brachial index (ABI) between 0.7-1.3 or dorsal transcutaneous oxygen partial pressure test >=30mmHg; 8. FBG less than 10mmol/L, glycated hemoglobin (HbA1c) less than 10% at randomization; 9. The presence of untreated dead bone is ruled out by X-ray, computed tomography (CT) scan, or magnetic resonance imaging (MRI); 10. Absence of underlying comorbidities that would adversely affect wound closure (cancer, Raynaud's syndrome, severe venous insufficiency, or uncorrected arterial hyposupply); 11. Concomitant drugs (cytotoxic drugs or chemotherapeutic drugs) that will affect wound closure are prohibited; 12. Patients voluntarily sign the informed consent form and participate in all procedures and follow-up evaluations required to complete the study.
Exclusion criteria
Exclusion criteria: 1. Patients with wound duration of more than 12 months; 2. Patients with diabetic foot with the following characteristics: (1) Patients with active osteomyelitis or dead bone, active cellulitis, sinus tract ulcer, or active deep vein thrombosis at the ulcer site to be treated by the investigator; (2) Patients with a =2× upper limit of normal (ULN), or creatinine >2.5mg/dl); 8. Patients who have pregnancy plans or are pregnant or lactating during the trial; 9. Patients with glycated hemoglobin >=10%; 10. Patients with known history of poor medical compliance or patients who are difficult to cooperate with hospital visits and treatment during the trial; 11. Other conditions judged by the investigator to be unsuitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of complete wound healing at 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage change in the area of the wound relative to the baseline on a weekly basis;The proportion of subjects whose wounds were completely closed by the 6th week;The rate of wound healing maintenance at the 2nd and 4th follow-up visits;The proportion of subjects who achieved >= 40% wound closure by the 6th week;The time taken for the wound to completely heal during the follow-up period;The cost of using decellularized bovine amniotic membrane and decellularized dermal matrix;Evaluation of the degree of pain perception of the wound during the treatment of the patient;Recurrence rate of ulcers during follow-up period; | — |
Countries
China
Contacts
Public ContactXingwu Ran
West China Hospital of Sichuan University
Outcome results
None listed