Use of PRP for the Healing of Grade III Ulcers

December 5, 2025 updated by: Hospital Mutua de Terrassa

Application of Platelet-rich Plasma for Healing og Grade III Ulcer.

Treatment with platelet-rich plasma (PRP) consists of extracting a small amount of blood from the patient himself, which is later processed by centrifugation to obtain a fraction rich in platelets. It will be done on weekly or fortnightly blood extraction procedure, depending on the process. Between 1-3 sterile citrate collection tubes will be used, which may vary depending on the size of the ulcer. Each tube can contain approximately 8-10ml of blood and the procedure is carried out under aseptic conditions and with material from a single use Once the sample has been centrifuged, the blood plasma will be extracted and the concentrate obtained will be applied directly on the wound or ulcer with the objective of stimulating and accelerating healing by means of growth factors.

This procedure is used as complementary therapy in chronic ulcers or with difficulty in healing, such as they can be venous, arterial, pressure or diabetic foot ulcers.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

  1. Introduction

    Platelet-rich plasma (PRP) is an autologous blood derivative obtained by centrifuging the patient's own blood. It contains a high concentration of growth factors that promote tissue regeneration and cell proliferation. Its use in the treatment of chronic ulcers has shown good results, especially in wounds that do not respond to conventional treatments.

  2. Required Materials

    Sterile 5 ml and 10 ml syringes

    Needles or butterfly needle and 20G vacutainer for extraction, and 30G (4 mm or 13 mm) for infiltration

    Tube with anticoagulant (3.8% sodium citrate), closed system technique

    Clinical centrifuge with fixed-angle or swinging-bucket rotor

    Gloves, mask, gown, and sterile working surface

    Sterile dressings, saline solution, and antiseptics

  3. Blood Extraction

    Draw between 10 and 20 ml of venous blood from the patient, depending on the extent of the ulcer. Use tubes with anticoagulant to prevent premature coagulation.

    Apply a closed system technique to avoid handling and contamination of the sample.

  4. Centrifugation

    Use a single centrifugation cycle to obtain high-quality PRP: 3500 rpm for 10 minutes.

    Once the process is complete, prepare the PRP in the selected 5 ml or 10 ml syringes.

  5. PRP Application

    → Before application:

    Clean the wound with saline solution and antiseptic.

    Perform debridement if there is necrotic or fibrinous tissue.

    → Application methods:

    Intradermal or subdermal perilesional infiltration using a fine needle (30G 4 mm or 30G 13 mm).

    Direct application of PRP onto the wound bed.

    Apply a topical layer.

    Cover with a sterile dressing or gauze soaked in the same PRP.

  6. Monitoring and Follow-Up

    Evaluate the wound weekly or biweekly.

    Repeat treatment every 1-2 weeks depending on progress.

    Take photographs and document each visit to assess clinical response.

  7. Contraindications and Precautions

    Severe thrombocytopenia (< 100,000 platelets/μL)

    Active systemic infection

    Severe hematological disorders

    Do not administer in case of allergy to the anticoagulants used

    Active local infection

  8. Conclusions

PRP represents an innovative and safe therapeutic option in the management of chronic ulcers, with good clinical outcomes and minimal side effects when performed using the appropriate technique.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Ametlla del Vallès, Barcelona, Spain, 08480
        • Centre d'Atenció Intermitja l'Ametlla del Vallès

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with Grade III ulcers.
  • Patients with ulcers older than two weeks.
  • Patients with an optimal platelet count according to prior laboratory tests.

Exclusion Criteria:

  • Patients with a palliative profile.
  • Patients with a limited life expectancy.
  • Patients with a platelet count below 10 × 10⁹/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Group receiving treatment with PRP
Procedure: PRP group
The PRP will be injected into the wound bed, unlike in other studies where it has been used only as a gel.
Active Comparator: Control Group
Group receiving standard/traditional care
Procedure: Classic treatment
Standard care for patients in the control group: Aquacel + Gel every 48 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in ulcer diameter at 30, 60, and 90 days
Time Frame: At the beginning of patient inclusion and at 30, 60, and 90 days from the start of therapy
At the beginning of patient inclusion and at 30, 60, and 90 days from the start of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scoring on the PUSH Scale
Time Frame: At the beginning of the study, and at 30, 60, and 90 days from the start of the therapy
The PUSH Scale assesses the area of the pressure ulcer (scored from 0 to 10), the amount of exudate (scored from 0 to 3), and the type of tissue (scored from 0 to 4). The higher the total score, the worse the condition of the ulcer
At the beginning of the study, and at 30, 60, and 90 days from the start of the therapy
Amount of Exudate
Time Frame: At the time of patient inclusion, and at 30, 60, and 92 days from the start of treatment
Amount of ulcer exudate, scored from 0 to 3
At the time of patient inclusion, and at 30, 60, and 92 days from the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Mutua de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssaigPRPBE0205
  • BE0205 (Other Identifier: Fundació per la Recerca Mutua Terrassa)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All patient data will be stored in the REDCAP system, which ensures the protection of patients' personal data.

IPD Sharing Time Frame

he data will be accessible only to the principal investigators of the study, from the start of the study (November 2025) until the completion of the data analysis (February 2028)

IPD Sharing Access Criteria

Only the principal investigators of the study will have access to the data, and the data can only be accessed through the REDCAP application

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcer

Clinical Trials on PRP group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe