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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07255391
Enrollment
50
Registered
2025-12-01
Start date
2025-12-31
Completion date
2028-04-30
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PRP Injection, Ulcer

Keywords

PRP, Úlceras Grado III

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.

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.

Interventions

PROCEDUREPRP group

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

Sponsors

Hospital Mutua de Terrassa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Control y experimental

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Change in ulcer diameter at 30, 60, and 90 daysAt the beginning of patient inclusion and at 30, 60, and 90 days from the start of therapy

Secondary

MeasureTime frameDescription
Scoring on the PUSH ScaleAt the beginning of the study, and at 30, 60, and 90 days from the start of the therapyThe 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
Amount of ExudateAt the time of patient inclusion, and at 30, 60, and 92 days from the start of treatmentAmount of ulcer exudate, scored from 0 to 3

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026