PRP ULCERAS: Clinical Trial Phase III

NCT02213952 | Withdrawn Phase 3 DMC

• 2 other identifiers: UIAPB-PRPULCERAS-2014-022014-001514-26
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all the assistance levels, and they have big repercussion referring to individual, social and labour levels, supposing a big consumption of human and material resources.The cure with autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the cicatrization time comparing to conventional methods in hospital levels, which becomes interesting contrasting its efficacy in primary care. AIM:Evaluate the efficacy of the autologous PRP in the treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP classification). DESIGN: A study will be executed, which will consist in a randomized clinical test, multicentered, in parallel groups and opened. 150 patients suffering of venous vascular ulcers will be studied, who will be between the age of 40-100 years old, and who will be attached to 10 health centers. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area decreasing", "CIVIQ index", "% one cure per week".

Conditions

Ulcer

Keywords

Ulcer; Platelet-Rich Plasma

Outcome Measures

Primary Outcomes (1)

• ULCER SIZE CHANGE

  Change from baseline at 9 weeks of the surface area of the ulcer, in cm2, measured using ImageJ software from the weekly the photographs of the wound.

  Change from baseline at 9 weeks

Secondary Outcomes (2)

• QUALITY OF LIFE (INDEX CIVIQ)

  Change from baseline at 9 weeks

• Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK

  Change from baseline at 9 weeks

Study Arms (2)

Platelet-Rich Plasma

EXPERIMENTAL

Our goal is to evaluate the efficacy of the autologous Platelet-Rich Plasma (PRP) in the treatment of vascular ulcers, comparing to the conventional treatment (cure with humid environment), in primary care patients with chronic venous ulcer.

Drug: Platelet-Rich Plasma

Usual treatment

ACTIVE COMPARATOR

Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours.

Other: Usual treatment

Interventions

Platelet-Rich Plasma DRUG

For obtaining autologous PRP, will be drawn from 9-30 ml of blood of the patient in sterile tubes containing 4.5 ml of 3.8% sodium citrate. The tubes will be centrifuged for 8 min at 580 Gs to separate the different blood components according to density gradient. After centrifugation, we will aspire the PRP. We will add CaCl2 to the PRP (50l per ml of liquid plasma). While the plasma will get gelified, we will cure the ulcer with saline cleaning and mechanical removal. Then the ulcer will be covered with gelified PRP and a secondary dressing. This cure will be done each 7 days.

Also known as: PRP

Platelet-Rich Plasma

Usual treatment OTHER

Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours.

Also known as: Osakidetza protocol of humid environment cure.

Usual treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from Barakaldo and Bilbao, who come to the treatment room at health centers in these towns belong to the OSI Ezkerraldea-Enkarterri-Cruces of Osakidetza-Basque Health Service.
• Men or women older than 18 years old.
• Patients with chronic venous insufficiency stage C-6 of the CEAP classification.
• Patients with vascular ulcers unresponsive to conventional treatment over a 2 months period or recurrence of previous venous ulcers.
• Patients who present an analytical before entering the studio, platelets and red blood cell count and hematocrit in normal range
• Ulcers whose diameter size is 30cm² or less.
• Greater Ankle Arm Index 0.8 and less than 1.5.
• Patients with recent analytic with number platelet and red blood cell count and hematocrit normal range.
• Patients with recent analytic negative to: Syphilis serology, Hepatitis B: HBsAg, Hepatitis C: Anti-HCV tests genomic nucleic acid amplification (NAT), HIV I / II: Anti-HIV I / II.
• Self or family support sufficient to move patients to the health center.
• Written informed consent of the patient

You may not qualify if:

• Patients on chronic immunosuppressive or retroviral.
• Coagulopathy
• Patients with chronic infectious diseases.
• Patients treated with radiotherapy or chemotherapy, or history of neoplasia.
• Patients with more than two active ulcers.
• Pregnant or childbearing potential not want to use contraception.
• Women breastfeeding.
• Patients with active infection or febrile syndrome at baseline.
• People who are taking a drug under clinical investigation or participated in any study under clinical investigation in the previous 30 days.

Sponsors & Collaborators

• Basque Health Service: lead
• Osakidetza: collaborator

Study Sites (2)

Comarca Enkarterri Ezkerraldea

Portugalete, Bizakaia, 48920, Spain

Location

UIAPB

Bilbao, Bizkaia, 48014, Spain

Location

Related Publications (1)

• San Sebastian KM, Lobato I, Hernandez I, Burgos-Alonso N, Gomez-Fernandez MC, Lopez JL, Rodriguez B, March AG, Grandes G, Andia I. Efficacy and safety of autologous platelet rich plasma for the treatment of vascular ulcers in primary care: Phase III study. BMC Fam Pract. 2014 Dec 30;15:211. doi: 10.1186/s12875-014-0211-8.

  PMID: 25547983 DERIVED

MeSH Terms

Conditions

Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kepa Mirena San Sebastian Moreno

  C. Ezkerraldea Enkarterri.

  PRINCIPAL INVESTIGATOR

• Igone Hernández Cabezas.

  C. Ezkerraldea Enkarterri

  STUDY CHAIR

• Igone Lobato García

  C. Ezkerraldea Enkarterri

  STUDY CHAIR

• Begoña Rodríguez Rodríguez.

  C. Bilbao

  STUDY CHAIR

• Ariadna Pérez Salvador

  C. Ezkerraldea Enkarterri

  STUDY CHAIR

• Gonzalo Grandes Odriozola

  Primary Care Research Unit of Bizkaia

  STUDY CHAIR

• Natalia Burgos Alonso.

  Primary Care Research Unit of Bizkaia

  STUDY DIRECTOR

• Anna Giné March

  Primary Care Research Unit of Bizkaia

  STUDY DIRECTOR

• Kepa Mirena San Sebastian Moreno

  C. Ezkerraldea Enkarterri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: August 12, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 25, 2020

Record last verified: 2020-02

Locations

ES (2)