Check the efficacy of PRP in vascular ulcers in primary care.

Efficacy of Autologous Platelet-Rich Plasma in the treatment of vascular ulcers in Primary Care: Clinical trial phase III. - PRP in vascular ulcers in Primary Care

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001514-26-ES

Enrollment

150

Registered

2014-06-09

Start date

2015-01-15

Completion date

Unknown

Last updated

2018-08-20

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

Conditions

Patients with venous leg ulcers, between 40-100 years old, assigned to ten health centers in the county Ezkerraldea-Enkarterri Osakidetza Basque Health Service. MedDRA version: 17.1 Level: HLT Classification code 10040796 Term: Skin and subcutaneous tissue ulcerations System Organ Class: 100000004858

Interventions

Product Name: PRP autologo Product Code: PRP AP Pharmaceutical Form: Cutaneous patch INN or Proposed INN: PRP 2012 CAS Number: 46465 Current Sponsor code: PRP 2012 Other descriptive name: PLATELETS Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients attending treatment room health centers this s localities, belonging to the Sanitary District of Ezkerraldea-Enkarterri Osakidetza-Basque Health Service. • Men and women older than 40 and younger than 100 years old. • Patients with chronic venous insufficiency stage C-6 of the CEAP classification. • Patients with vascular ulcers unresponsive to conventional treatment for a longer than 2 months period. • Patients who present an analytical with a normal platelet count and number of serological tests, Hepatitis B: HBsAg, Hepatitis Syphilis negative red blood cells and hematocrit in normal range, and C: Anti-HCV testing genomic amplification and nucleic acid (NTA), HIV I / II: Anti-HIV I / II. • One or two together ulcers whose area is equal to or less than 20 cm². • Ankle Arm index greater than 0.8 and less than 1.5. • self-sufficient family support or to scroll to the health center patients. • written informed consent from the patient 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75

Exclusion criteria

Exclusion criteria: • Patients on chronic immunosuppressive or retrovirals. • Coagulopathies. • Patients with chronic infectious diseases: Syphilis, Hepatitis B, Hepatitis C, HIV. • Patients treated with radiotherapy or chemotherapy. • Patients with history of neoplasia. • Patients with more than two active ulcers. • Women are breastfeeding or of childbearing age who do not wish to use effective contraception during the clinical trial. • Patients with active infection or febrile syndrome at baseline. • Patients with ABI less than 0.8 or greater than 1.5. • People who are taking a drug undergoing clinical investigation or have been involved in some phasing plug clinical research study in the previous 30 days.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficiency associated with autologous PRP estimating the reduction in ulcer area by assessing serial photographs at baseline, one month of treatment and two months after the start of treatment, compared with that observed in the control group.;Secondary Objective: Evaluate the autologous PRP safety in the treatment of venous ulcers in patients with chronic venous insufficiency (stage C-6 in APEC classification), describing the reduction of pain of patients, the percentage of ulcers with infections, perilesional involvement, all in two groups and performing the comparison. Estimating the quality of life of patients by CIVIQ index in both groups at baseline, one month of treatment and two months of treatment.;Primary end point(s): ULCER SIZE CHANGE QUALITY OF LIFE (INDEX CIVIQ) SAFETY PAIN (EVA);Timepoint(s) of evaluation of this end point: Basal, 5th week and 9th week. The holding period of each patient will be 9 weeks, plus a systematic review of the medical records of the study participants at two years to detect possible long-term side effects related to carcinogenicity.	—

Measure

Time frame

Main Objective: To evaluate the efficiency associated with autologous PRP estimating the reduction in ulcer area by assessing serial photographs at baseline, one month of treatment and two months after the start of treatment, compared with that observed in the control group.;Secondary Objective: Evaluate the autologous PRP safety in the treatment of venous ulcers in patients with chronic venous insufficiency (stage C-6 in APEC classification), describing the reduction of pain of patients, the percentage of ulcers with infections, perilesional involvement, all in two groups and performing the comparison. Estimating the quality of life of patients by CIVIQ index in both groups at baseline, one month of treatment and two months of treatment.;Primary end point(s): ULCER SIZE CHANGE QUALITY OF LIFE (INDEX CIVIQ) SAFETY PAIN (EVA);Timepoint(s) of evaluation of this end point: Basal, 5th week and 9th week. The holding period of each patient will be 9 weeks, plus a systematic review of the medical records of the study participants at two years to detect possible long-term side effects related to carcinogenicity.

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Secondary

Measure	Time frame
Secondary end point(s): AT-RISK OCCUPATION BODY WEIGHT HEIGHT BMI HISTORY OF THROMBOSIS TROPHIC LESION CAUSE OF THE LESION DISEASE COURSE PERIOD OF CONVENTIONAL TREATMENT COMPRESSION THERAPY PHLEBOTROPIC DRUGS PREVIOUS LESIONS SITE OF THE ULCER DIABETES ANKLE BRACHIAL INDEX TYPE OF DEBRIDEMENT NON-VIABLE TISSUE INFECTION PAIN WOUND EDGE LEG OEDEMA WOUND LENGTH WOUND WIDTH AMOUNT OF BLOOD TAKEN HEALING TIME NUMBER OF TREATMENT SESSIONS CHANGE PRIMARY DRESSING CHANGE SECONDARY DRESSING;Timepoint(s) of evaluation of this end point: Basal, 5th week and 9th week. The holding period of each patient will be 9 weeks, plus a systematic review of the medical records of the study participants at two years to detect possible long-term side effects related to carcinogenicity.	—

Measure

Time frame

Secondary end point(s): AT-RISK OCCUPATION BODY WEIGHT HEIGHT BMI HISTORY OF THROMBOSIS TROPHIC LESION CAUSE OF THE LESION DISEASE COURSE PERIOD OF CONVENTIONAL TREATMENT COMPRESSION THERAPY PHLEBOTROPIC DRUGS PREVIOUS LESIONS SITE OF THE ULCER DIABETES ANKLE BRACHIAL INDEX TYPE OF DEBRIDEMENT NON-VIABLE TISSUE INFECTION PAIN WOUND EDGE LEG OEDEMA WOUND LENGTH WOUND WIDTH AMOUNT OF BLOOD TAKEN HEALING TIME NUMBER OF TREATMENT SESSIONS CHANGE PRIMARY DRESSING CHANGE SECONDARY DRESSING;Timepoint(s) of evaluation of this end point: Basal, 5th week and 9th week. The holding period of each patient will be 9 weeks, plus a systematic review of the medical records of the study participants at two years to detect possible long-term side effects related to carcinogenicity.

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Countries

Spain

Contacts

Public ContactNatalia Burgos Alonso

Unidad de investigacion de atencion Primaria de Bizakaia

natalia.burgosalonso@osakidetza.net0034946006637

Outcome results

None listed

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