Use of PRP for the Healing of Grade III Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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PRP Injection Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control y experimental

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

Group receiving treatment with PRP

Group Type EXPERIMENTAL

PRP group

Intervention Type PROCEDURE

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

Control Group

Group receiving standard/traditional care

Group Type ACTIVE_COMPARATOR

Classic treatment

Intervention Type PROCEDURE

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

Interventions

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PRP group

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

Intervention Type PROCEDURE

Classic treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.