Allogeneic Blood Transfusions, Diabetic Wounds, Platelet Rich Plasma, Renal Dysfunction
Conditions
Keywords
Diabetic wounds, Platelet Rich Plasma, allogeneic blood, renal dysfunction
Brief summary
Diabetic wounds are difficult to heal. Autologous platelets in diabetic patients with renal insufficiency have poor function. Allogeneic platelet plasma has a promising application prospect. Comparing the efficacy and safety differences between allogeneic platelet plasma and autologous platelet plasma is of significant importance and value for the clinical application.
Detailed description
This study is a single-center, randomized, parallel control, superior trial. Fifty-six renal dysfunction patients with diabetic-related wound after wound bed preparation will be randomly assigned to the autologous platelet plasma group and allogeneic platelet plasma group in a 1:1 ratio. The primary outcome is the wound healing rate at 4 weeks (Stitches removal). The secondary outcomes include the wound healing rates at 3 weeks, the reduction rate of wound area at 2-, 3- and 4- weeks, healing time, post-operative wound infection, 7-day, 2-, 3-, 4-week pain relief progression assessed by Visual Analog Scale, incidence of mortality, reoperation, and adverse events during the follow-up period.
Interventions
DRUGallogeneic platelet plasma
Al-PRP derived from healthy blood donors
DRUGautologous platelet plasma
Autologous platelet-rich plasma from the patient themselves
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is aged 18-80 years old; 2. Diagnosed as type 1 or type 2 diabetes according to the World Health Organization standard, blood sugar has been controlled before enrollment, and the level of Glycated hemoglobin HbA1c is less than 10%; 3. Abnormal renal function defined as: * Serum creatinine \>106 μmol/L (men) or \>97 μmol/L (women) * AND eGFR \<90 mL/min/1.73m² (CKD-EPI) ； 4. The patient has diabetes wounds with poor healing or prolonged healing need standard wound treatment; 5. After preparing the wound bed, the condition for using platelet plasma to close the wound is met\*; 6. Voluntarily sign an informed consent form;
Exclusion criteria
1. Blood glucose is out of control or not yet effectively controlled，; 2. Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; 3. Active bleeding inside the wound, and routine basic treatment plans cannot be implemented； 4. Uncontrolled systemic or disseminated infections; 5. Patients with advanced malignant tumors; 6. Pregnant or lactating women； 7. The patient is unable to cooperate or has mental disorders; 8. According to the judgment of the researchers, the patient has a clear and irremovable cause that affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the wound healing rate at 4 weeks | by the end of 4 weeks | calculated as the percentage of healed wounds by the end of 4 weeks |
Countries
China
Contacts
Primary ContactLong Zhang Executive Deputy Director, Medical Doctor
Outcome results
None listed