NCT07255391

Use of PRP for the Healing of Grade III Ulcers

Application of Platelet-rich Plasma for Healing og Grade III Ulcer.

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hospital Mutua de Terrassa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
PROCEDURE	PRP group	The PRP will be injected into the wound bed, unlike in other studies where it has been used only as a gel.
PROCEDURE	Classic treatment	Standard care for patients in the control group: Aquacel + Gel every 48 hours

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2028-04-01
• First posted: 2025-12-01
• Last updated: 2025-12-12

Locations

1 site across 1 country: Spain