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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous platelet plasma group | Active Comparator | diabetic-related wounds after wound bed preparation are treated by the autologous platelet plasma |
|
| allogeneic platelet plasma group | Experimental | diabetic-related wounds after wound bed preparation are treated by the allogeneic platelet plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic platelet plasma | Drug | Al-PRP derived from healthy blood donors |
|
| Measure | Description | Time Frame |
|---|---|---|
| the wound healing rate at 4 weeks | calculated as the percentage of healed wounds by the end of 4 weeks | by the end of 4 weeks |
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Inclusion Criteria:
The patient is aged 18-80 years old;
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%;
Abnormal renal function defined as:
The patient has diabetes wounds with poor healing or prolonged healing need standard wound treatment;
After preparing the wound bed, the condition for using platelet plasma to close the wound is met*;
Voluntarily sign an informed consent form;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Zhang Executive Deputy Director, Medical Doctor | Contact | +86 010-82266699 | liyunfeng1106@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
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| autologous platelet plasma | Drug | Autologous platelet-rich plasma from the patient themselves |
|
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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