Clinical trial to evaluate the effectiveness in the healing of chronic venous leg ulcers of rich in platelets plasma treatment.

RANDOMIZED STUDY TO CHECK THE EFFECTIVENESS OF TOPICAL TREATMENT WITH PLATELET- RICH PLASMA IN THE HEALING OF LOWER LIMBS' VENOUS CHRONIC ULCERS - PULCRO

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000314-29-ES

Enrollment

Unknown

Registered

2017-03-31

Start date

2017-05-31

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

Venous ulcers in lower limbs MedDRA version: 19.1 Level: LLT Classification code 10045373 Term: Ulcers of extremities System Organ Class: 100000004858 MedDRA version: 20.0 Level: LLT Classification code 10024946 Term: Lower extremities ulcers of System Organ Class: 100000004858

Interventions

Product Name: PRGF Endoret Pharmaceutical Form: Concentrate for cutaneous solution INN or Proposed INN: Platelet-Rich Plasma Current Sponsor code: BTI:KMU-HE Other descriptive name: PLATELETS, HUMAN B

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age> 18 years. 2. Ambulation without assistance by other people or by orthoses to perform daily activities. 3. Ulcer below the knee, with venous etiology, which does not present clinical improvement or reduction of the area after 6 weeks of cures in our center. 4. Pedal / tibial posterior pulse present or heel-arm index (ITB)> 0.8. 5. Be able to provide informed consent prior to randomization and agree to comply with all procedures included in this protocol, including the follow-up phase. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 1. Ischemic aetiology's ulcers. 2. Ulcers of more than 6 weeks of evolution but with tendency to cicatrization (by photographic comparison with the previous week). 3. Patients of childbearing age with a positive pregnancy test on the day of screening. 4. Female patients who are breastfeeding 5. Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To verify the effectiveness of topical treatment with platelet-rich plasma in the healing of chronic lower limb venous ulcers.;Secondary Objective: - Localized pain in the ulcer decreases - Improvement in the physical affection as a result of the disease. - Improvement in the mental affectation as a result of the disease. - Adverse side effects incidence.;Primary end point(s): Ulcer area: Weekly photographs will be taken with centimetric reference. Subsequently, the area will be calculated by a computer program (Acrobat®) by a blind investigator who does not know which group belongs to the ulcer;Timepoint(s) of evaluation of this end point: From day 0 (start of the trial) to week 52.	—

Measure

Time frame

Main Objective: To verify the effectiveness of topical treatment with platelet-rich plasma in the healing of chronic lower limb venous ulcers.;Secondary Objective: - Localized pain in the ulcer decreases - Improvement in the physical affection as a result of the disease. - Improvement in the mental affectation as a result of the disease. - Adverse side effects incidence.;Primary end point(s): Ulcer area: Weekly photographs will be taken with centimetric reference. Subsequently, the area will be calculated by a computer program (Acrobat®) by a blind investigator who does not know which group belongs to the ulcer;Timepoint(s) of evaluation of this end point: From day 0 (start of the trial) to week 52.

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Secondary

Measure	Time frame
Secondary end point(s): • Pain: Measured using the WHO Visual Analog Scale. • Physical and mental component: It will be calculated using the standardized SF-12 quality of life questionnaire. • Adverse Events (AA): Any sign, symptom or undesirable clinical condition that occurs after the start of treatment is considered to be AA. Information about all AAs, whether they are voluntarily communicated by the patient, discovered by the investigator or detected on the physical examination will be recorded in an open general questionnaire.;Timepoint(s) of evaluation of this end point: From day 0 (start of the trial) to week 52	—

Measure

Time frame

Secondary end point(s): • Pain: Measured using the WHO Visual Analog Scale. • Physical and mental component: It will be calculated using the standardized SF-12 quality of life questionnaire. • Adverse Events (AA): Any sign, symptom or undesirable clinical condition that occurs after the start of treatment is considered to be AA. Information about all AAs, whether they are voluntarily communicated by the patient, discovered by the investigator or detected on the physical examination will be recorded in an open general questionnaire.;Timepoint(s) of evaluation of this end point: From day 0 (start of the trial) to week 52

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Countries

Spain

Contacts

Public ContactUCICEC

Unidad Central de Ensayos Clínicos

hoi.tong@idipaz.es0034912071466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026