Peking University 3rd Hospital
Beijing, Beijing Municipality, 010, China
NCT Number: NCT05979584
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 010, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 4-week
By D28, the proportion of healed wounds in the total number of cases
Time frame: 4-week
(pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%
Time frame: 8-week
by the end of 8 weeks, the proportion of healed wounds to the total number of cases
Time frame: day 0
Time frame: day 0
Time frame: during the follow-up period
such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation
Time frame: during the follow-up period
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
Peking University Third Hospital
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07690566
Cardiovascular Diseases, Diabetes Complications
Minya, Egypt
View Trial DetailsNCT05579743
Cardiovascular Diseases, Diabetes Complications
Baltimore, Maryland, United States
View Trial DetailsNCT02378493
Bacterial Infections, Bacterial Infections and Mycoses
Clermont-Ferrand, France
View Trial DetailsNCT07553468
Cardiovascular Diseases, Diabetes Complications
León, León Department, Nicaragua
View Trial Details