Diabetic foot
Conditions
Interventions
Group A:Angioplasty to dilate blood vessels
Group B:Angioplasty was first used to dilate the blood vessels, and then 10 ml of umbilical cord mesenchymal stem cells were locally injected.
Sponsors
The First People's Hospital of Hefei
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 - 65 years old male and female; 2) Diabetic foot ulcer grading Wagner grade 2 (ulcer deep fascia) and above, and Rutherford grade 1 (mild intermittent claudication, complete treadmill test, brachial artery pressure after exercise > 50mmHg, but at rest The radial artery pressure is less than about 20 mmHg) and above; 3) The patient was stabilized by blood glucose control within three months before treatment. In addition to controlling blood glucose drugs, the relevant vasodilator drugs and drugs for improving blood supply to the lower extremities were not used; 4) The patient is in good health except for diabetes-related symptoms associated with diabetes; 5) The subject or his legal representative is required to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who studied recent related surgery in the limbs; 2) Study the severed infection of the face of the ulcer in the past week, or a systemic infection; 3) Wagner grade 0 (no ulcer) and grade 1 (ulcer limited to skin), or Rutherford grade 0 (no clinical symptoms, treadmill test or reactive hyperemia test is normal, no hemodynamic performance without arterial obstruction); 4) Overweight, body mass index (BMI) > 30 (obesity class II); 5) The patient has coagulopathy, poorly controlled diabetes or other doctors believe it is a contraindication to interference with cartilage repair; 6) Patients have alcohol or drug abuse in the past 6 months; 7) The patient has any potential or current medically-accepted mental illness (which may affect the assessment of the subject); 8) Uncontrolled bacterial, fungal or viral patients with severe systemic or local infection, including hepatitis A, hepatitis B, hepatitis C, HIV, syphilis positive patients; 9) Patients with severe cardiac dysfunction, such as left ventricular ejection rate < 50%; patients with right ventricular failure, arrhythmia and other dysfunction; 10) Uncontrolled high blood pressure or congestive heart failure, active angina requiring nitrate, myocardial infarction or arrhythmia or heart failure requiring active treatment in the past 6 months; 11) Patients with pulmonary hypertension; 12) Patients with diffuse alveolar hemorrhage and other progressive lung disease may require a mask or other auxiliary machinery to maintain blood oxygen levels; hypoxemia, oxygen saturation < 90%; 13) Respiratory failure with restrictive or obstructive pulmonary disease or ventilator support; 14) In patients with severe liver dysfunction, alanine aminotransferase, total bilirubin is more than 3 times the normal maximum value; 15) Severe hepatic vein occlusive disease or sinus obstruction; 16) Severe renal insufficiency, creatinine is more than 2 times the normal maximum; creatinine clearance is < 30 mL/min; 17) Pregnant women or patients planning to become pregnant, breast-feeding patients; 18) Patients who are participating in other clinical trials; 19) Severe allergies and patients known to be allergic to hyaluronic acid products; 20) The researchers believe that other reasons are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brachial artery pressure;Degree of ulcer; | — |
Countries
China
Contacts
Public ContactGao Bin
The First People's Hospital of Hefei
Outcome results
None listed