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Enrolling by Invitation

NCT Number: NCT07255391

Use of PRP for the Healing of Grade III Ulcers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre d'Atenció Intermitja l'Ametlla del Vallès

L'Ametlla del Vallès, Barcelona, 08480, Spain

About this study

  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PRP group

Procedure

The PRP will be injected into the wound bed, unlike in other studies where it has been used only as a gel.

Classic treatment

Procedure

Standard care for patients in the control group: Aquacel + Gel every 48 hours

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Hospital Mutua de Terrassa

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 1, 2025
Registry last updated
Dec 12, 2025

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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