Diabetic Foot Ulcer
Conditions
Keywords
Diabetic Foot Ulcer, Umbilical cord blood mononuclear cells
Brief summary
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
Detailed description
The difficulty in the healing of diabetic foot is related to the loss of local repair microenvironment. The platelet rich plasma (PRP) can improve the repair ability, however, the requirement for wound bed preparation is strict, or treatment failure may occur. Umbilical cord blood mononuclear cells (MNC) may provide a better repair environment through paracrine action. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
Interventions
DRUGUmbilical cord blood mononuclear cell gel（MNC）
Local wound treatment by combination of PRP and MNC, once;
DRUGThe platelet rich plasma（PRP）
Local wound treatment by PRP alone, once.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The age of the patients is 18-80 years old; 2. Diabetic foot is diagnosed and Wagner grade is above Ⅱ; 3. The duration of ulcer is 2 months or more, with no healing trend for 2 weeks or more. 4. Fasting blood glucose ≤ 9mmol / L, 2 hours postprandial blood glucose ≤ 13mmol / L; 5. The skin oxygen partial pressure around the wound is more than 20mmHg; 6. Sign written informed consent.
Exclusion criteria
1. Acute spreading infection of the wound, e.g. massive exudation, redness, swelling, heat, pain. 2. Acute myocardial infarction, heart failure, hepatitis; 3. Active bleeding or hematoma in the wound; 4. Serum albumin \<25g/L; 5. Hemoglobin \<80g/L; 6. Platelets \<50×109/L; 7. Poor cooperate or compliance;The patient cannot cooperate or is. 8. Mentally disabled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound area reduction rate | one week | The ratio of the reduced area after one week of treatment to the original area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing rate at 4 weeks | 4 weeks | Percentage of patients with healed wound at 4 weeks |
| Amputation rate at 8 weeks | 8 weeks | Percentage of patients with major amputation at 8 weeks |
Countries
China
Contacts
Primary ContactLong Zhang, Dr.
Backup ContactWen-Hui Wang, Dr.
Outcome results
None listed