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Completed

NCT Number: NCT05979584

Platelet Rich Plasma VS Platelet Fibrin Plasma in Treatment of Diabetes Related Wound:a Randomized Controlled Trial

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University 3rd Hospital

Beijing, Beijing Municipality, 010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%;
  • diabetes wounds with poor healing or prolonged healing need standard wound treatment;
  • There is no disseminated infection or the disseminated infection has been controlled;
  • 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

  • Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet;
  • Severe ischemia of the wound surface, unable to seek medical attention or not yet corrected;
  • Uncontrolled systemic or disseminated infections;
  • Blood glucose is out of control or not yet effectively controlled;
  • Blood system diseases with uncorrected coagulation dysfunction or platelet dysfunction;
  • There is active bleeding inside the wound, and routine basic treatment plans cannot be implemented;
  • Platelets ≤ 80 × 10^9, hemoglobin<90g/L;
  • Patients with advanced malignant tumors;
  • Active period of autoimmune diseases;
  • The patient is unable to cooperate or has mental disorders;
  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 4-week wound healing rate

    Time frame: 4-week

    By D28, the proportion of healed wounds in the total number of cases

Secondary outcomes

  1. The 4-week wound area reduction rate

    Time frame: 4-week

    (pre-treatment wound area - post-treatment wound area)/pre-treatment wound area × 100%

  2. The 8-week wound healing rate

    Time frame: 8-week

    by the end of 8 weeks, the proportion of healed wounds to the total number of cases

  3. Total blood volume required to prepare platelet plasma

    Time frame: day 0

  4. Extracted platelet plasma volume

    Time frame: day 0

  5. adverse events related to blood collection during the follow-up period

    Time frame: during the follow-up period

    such as ecchymosis/hematoma/bleeding, thrombophlebitis, and unstable circulation

  6. Infection evaluation

    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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2023
Registry last updated
Apr 17, 2026

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.

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