Diabetic foot ulcer
Conditions
Interventions
Experimental group:Amniotic Membrane Micro Stent Therapy
Control group:Routine dressing
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-60 years, regardless of gender; 2. Patients diagnosed with diabetic foot ulcer; 3. Chronic ulcer time is longer than 4 weeks and less than 52 weeks; 4. The ulcer is located on the sole or back; 5. The ulcer area is between 2 square centimeters and 8 square centimeters; 6. The affected limb has sufficient blood perfusion. Ankle-brachial index 0.65-1.3, or transcutaneous oxygen partial pressure > 40 mmHg, or Doppler ultrasound shows sufficient blood flow; 7. After debridement, the ulcer wound should be separated from other ulcer edges by at least 2 cm; 8. According to GCP regulations, obtain informed consent and have signed the informed consent form, and volunteer to take the test.
Exclusion criteria
Exclusion criteria: 1. The condition is serious and life-threatening; 2. Severe heart, liver, kidney, lung insufficiency and other diseases; 3. Have mental illness, including severe hysteria, and have no autonomy; 4. Women who are pregnant or breastfeeding, or women who are planning to become pregnant; 5. There are tumors, cancers, etc.; 6. Diseases such as stroke or accompanied by autonomic nerve dysfunction of limbs and skin; 7. Participated in other clinical trials in the last 3 months; 8. According to the researcher's judgment, any medical history that may interfere with the test results or increase the patient's risk; 9. Serious infections such as cellulitis or osteomyelitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average wound healing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total wound closure rate;Ulcer recurrence rate;Medical fee; | — |
Countries
China
Contacts
Public ContactJi Shizhao
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed