Use of PRP for the Healing of Grade III Ulcers

NCT07255391 | Enrolling By Invitation Phase 4

• 2 other identifiers: AssaigPRPBE0205BE0205
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PRP Injection; Ulcer

Keywords

PRP; Úlceras Grado III

Outcome Measures

Primary Outcomes (1)

• Change in ulcer diameter at 30, 60, and 90 days

  At the beginning of patient inclusion and at 30, 60, and 90 days from the start of therapy

Secondary Outcomes (2)

• Scoring on the PUSH Scale

  At the beginning of the study, and at 30, 60, and 90 days from the start of the therapy

• Amount of Exudate

  At the time of patient inclusion, and at 30, 60, and 92 days from the start of treatment

Study Arms (2)

Experimental Group

EXPERIMENTAL

Group receiving treatment with PRP

Procedure: PRP group

Control Group

ACTIVE COMPARATOR

Group receiving standard/traditional care

Procedure: Classic treatment

Interventions

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.

Experimental Group

Classic treatment PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Mutua de Terrassa: lead

Study Sites (1)

Centre d'Atenció Intermitja l'Ametlla del Vallès

L'Ametlla del Vallès, Barcelona, 08480, Spain

Location

Related Publications (4)

• Sánchez-García S, Fernández-Parra R, Villanueva E, García-Hernández A, García-García F, García-Sánchez E. Uso del plasma rico en plaquetas en el tratamiento de úlceras vasculares: nuestra experiencia. Angiología. 2020;72(1):15-22.

  BACKGROUND

• Lázaro-Martínez JL, García-Álvarez Y, García-Morales E, Alvaro-Afonso FJ, Molines-Barroso RJ. Eficacia del plasma rico en plaquetas en la cicatrización de úlceras del pie diabético: una revisión sistemática y metaanálisis. Endocrinol Diabetes Nutr. 2019;66(3):187-94.

  BACKGROUND

• Knighton DR, Doucette M, Fiegel VD, Ciresi K, Butler E, Austin L. The use of platelet derived wound healing formula in human clinical trials. Prog Clin Biol Res. 1988;266:319-29. No abstract available.

  PMID: 3289047 BACKGROUND

• Rodriguez-Flores J, Palomar-Gallego MA, Enguita-Valls AB, Rodriguez-Peralto JL, Torres J. Influence of platelet-rich plasma on the histologic characteristics of the autologous fat graft to the upper lip of rabbits. Aesthetic Plast Surg. 2011 Aug;35(4):480-6. doi: 10.1007/s00266-010-9640-5. Epub 2010 Dec 24.

  PMID: 21184066 BACKGROUND

MeSH Terms

Conditions

Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control y experimental

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• 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)
• 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

Locations

ES (1)