A Phase 4 interventional study of PRP group and Classic treatment in PRP Injection and Ulcer, sponsored by Hospital Mutua de Terrassa. Enrolling by invitation at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Hospital Mutua de Terrassa · Phase 4, Interventional, and Treatment
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.
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
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.
359 studies on the registry are indexed under Ulcer; 62 are open to participants now.
This study's planned enrollment of 50 is below the median of 65 across 291 interventional studies indexed under Ulcer.
Browse Ulcer studies →Hospital Mutua de Terrassa is the lead sponsor of 35 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group receiving treatment with PRP
Procedure: PRP group
Group receiving standard/traditional care
Procedure: Classic treatment
The PRP will be injected into the wound bed, unlike in other studies where it has been used only as a gel.
Standard care for patients in the control group: Aquacel + Gel every 48 hours
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
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
Time frame: At the beginning of the study, and at 30, 60, and 90 days from the start of the therapy
Amount of Exudate
Amount of ulcer exudate, scored from 0 to 3
Time frame: At the time of patient inclusion, and at 30, 60, and 92 days from the start of treatment
Plan to share: Yes — All patient data will be stored in the REDCAP system, which ensures the protection of patients' personal data.
Supporting information: Statistical analysis plan
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
Start is estimated for Dec 2025; primary completion for Dec 2027, 24 months later.
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Hospital Mutua de Terrassa