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PRP InjectionPhase 4NCT07255391

Use of PRP for the Healing of Grade III Ulcers

A Phase 4 study testing PRP group and Classic treatment in people with PRP Injection and Ulcer, run by Hospital Mutua de Terrassa at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PRP Injection, Ulcer
What is being tested?
PRP group and Classic treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
Dec 2025to Apr 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

  • Centre d'Atenció Intermitja l'Ametlla del Vallès

    L'Ametlla del Vallès, Barcelona, 08480

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
PRP Injection, Ulcer
Being tested
PRP group, Classic treatment
Keywords
PRP, Úlceras Grado III
Medical subject headings
Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRP groupProcedure or surgery

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

  • Classic treatmentProcedure or surgery

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

Study groups in NCT07255391
Study groupRoleWhat they receive
Experimental GroupExperimentalGroup receiving treatment with PRP
Receives: Procedure: PRP group
Control GroupActive comparatorGroup receiving standard/traditional care
Receives: Procedure: Classic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in ulcer diameter at 30, 60, and 90 days

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

Secondary outcomes (2)

  1. Scoring on the PUSH Scale

    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

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

  2. Amount of Exudate

    Amount of ulcer exudate, scored from 0 to 3

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Control y experimental
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255391
Sponsor's protocol ID
AssaigPRPBE0205
Other IDs
BE0205
Status last verified
Dec 2025
First submitted
20 Nov 2025
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All patient data will be stored in the REDCAP system, which ensures the protection of patients' personal data.

Publications

  • 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.

  • 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.

  • 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.

    PubMed 3289047

  • 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.

    PubMed 21184066

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PRP group and Classic treatment in people with PRP Injection and Ulcer, run by Hospital Mutua de Terrassa at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07255391, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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