Centre d'Atenció Intermitja l'Ametlla del Vallès
L'Ametlla del Vallès, Barcelona, 08480, Spain
NCT Number: NCT07255391
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
L'Ametlla del Vallès, Barcelona, 08480, Spain
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.
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
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.
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.
→ 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.
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.
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: At the beginning of patient inclusion and at 30, 60, and 90 days from the start of therapy
Time frame: At the beginning of the study, and at 30, 60, and 90 days from the start of the therapy
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 time of patient inclusion, and at 30, 60, and 92 days from the start of treatment
Amount of ulcer exudate, scored from 0 to 3
Hospital Mutua de Terrassa
Other
Application of Platelet-rich Plasma for Healing og Grade III Ulcer.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07689383
PRP Injection, Rotator Cuff Injuries
Kifissia, Attica, Greece
View Trial DetailsNCT07282314
Adnexal Diseases, Endocrine System Diseases
View Trial DetailsNCT06932614
Arthritis, Joint Diseases
Taipei, Taiwan
View Trial DetailsNCT07115797
PRP Injection, TMD
View Trial Details