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: * Whether the Platelet Fibrin Plasma have noninferior efficacy than Platelet Rich Plasma in treatment of diabetes foot ulcer? * Whether the Platelet Fibrin Plasma have noninferior safety than Platelet Rich Plasma in treatment of diabetes foot ulcer? Participants will be assigned with a 1:1 ratio into intervention group and control group. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
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.
Peking University 3rd Hospital
Beijing, Beijing Municipality, China
4-week wound healing rate
By D28, the proportion of healed wounds in the total number of cases
Time frame: 4-week
The 4-week wound area reduction rate
(pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%
Time frame: 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
Time frame: 8-week
Total blood volume required to prepare platelet plasma
Time frame: day 0
Extracted platelet plasma volume
Time frame: day 0
adverse events related to blood collection during the follow-up period
such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation
Time frame: 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
Time frame: during the follow-up period
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