Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this randomized control trial is to compare the efficacy and safety of Platelet Rich Plasma VS Platelet Fibrin Plasma in patients with diabetes foot ulcer. The main question it aims to answer are:
Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet Fibrin Plasma | Experimental | Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. |
|
| Platelet Rich Plasma | Placebo Comparator | Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Fibrin Plasma | Device | Participants of intervention group will receive Platelet Fibrin Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. |
| Measure | Description | Time Frame |
|---|---|---|
| 4-week wound healing rate | By D28, the proportion of healed wounds in the total number of cases | 4-week |
| Measure | Description | Time Frame |
|---|---|---|
| The 4-week wound area reduction rate | (pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100% | 4-week |
| The 8-week wound healing rate | by the end of 8 weeks, the proportion of healed wounds to the total number of cases |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University 3rd Hospital | Beijing | Beijing Municipality | 010 | China |
Not provided
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Platelet Rich Plasma | Device | Participants of intervention group will receive Platelet Rich Plasma in addition with clinical optimal treatment plan after the wound bed preparation for closure. |
|
| 8-week |
| Total blood volume required to prepare platelet plasma | day 0 |
| Extracted platelet plasma volume | day 0 |
| adverse events related to blood collection during the follow-up period | such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation | during the follow-up period |
| Infection evaluation | 0 points for no infection and 1 point for local infection reduction, 2 points for local infection maintenance or aggravation, and 3 points for disseminated infections | during the follow-up period |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |