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Use of PRP for the Healing of Grade III Ulcers

H

Hospital Mutua de Terrassa

Status and phase

Invitation-only
Phase 4

Conditions

Ulcer
PRP Injection

Treatments

Procedure: Classic treatment
Procedure: PRP group

Study type

Interventional

Funder types

Other

Identifiers

NCT07255391
AssaigPRPBE0205
BE0205 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Experimental Group
Experimental group
Description:
Group receiving treatment with PRP
Treatment:
Procedure: PRP group
Control Group
Active Comparator group
Description:
Group receiving standard/traditional care
Treatment:
Procedure: Classic treatment

Trial contacts and locations

1

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Central trial contact

Cristina G Granado Calvillo, Enfermeria; Cristina Z Zambrana Calderon, Enfermeria

Data sourced from clinicaltrials.gov

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