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NCT Number: NCT01817218

Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers

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 practicability, security and potential 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 pilot study will be executed, which will consist in a randomized clinical test, multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers will be studied, who will be between the age of 40-80 years old, and who will be attached to five 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" .

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Key information

Conditions

Chronic Ulcer

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Comarca Enkarterri Ezkerraldea

Portugalete, Bizakaia, 48920, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients resident in Barakaldo, who are seen in treatment rooms at the Zaballa outpatient clinic or one of the following health centres: Zaballa, La Paz, Urban, or San Vicente, in the Ezkerraldea-Enkarterri Health Region of the Basque Health Service - Osakidetza.
  • Men or women of 40 to100 years of age
  • Patients with stage C6 chronic venous insufficiency according to the CEAP classification
  • Patients with vascular ulcers which have not responded to conventional treatment in 2 to 6 months
  • Patients who present an analytical before entering the study with a normal range of number of platelets, red blood cells and hematocrit
  • An ulcer of 3-5 cm in diameter
  • An ABI of greater than or equal to 0.8 or less than or equal to 1.5.
  • Independent patients or with sufficient family support
  • Patients have given written informed consent

Exclusion criteria

  • Patients with chronic treatment with immunosuppressive or retroviral drugs
  • Coagulopathies
  • Patients with chronic infectious diseases
  • Patients under radiotherapy or chemotherapy
  • Patients with a history of neoplasia
  • Patients with more than two active ulcers
  • Pregnant women
  • Patients with active cellulitis or fever
  • An ABI of less than 0.8 or more than 1.5.

Treatment and study plan

Platelet rich plasma

Drug

Osakidetza protocol

Device

Patients in the control group will be treated following the recommendations of the Ezkerraldea-Enkarterri Health Region, that is, using a moist healing environment (as described in "Uso racional de los productos de cura en ambiente húmedo. Plan de formación continuada de Osakidetza", 2011).

The type of material used to treat and dress the wound will be chosen after the assessment of the wound and surrounding skin, type and quantity of exudate and whether there are signs of infection. Wound care will be carried out every 48-72 hours, as is the current usual practice.

Other names: "Antimicrobial debridin", "hydrocolloids", "alginates and hydrofibres", "polyurethane foams", "barrier products"

Primary outcomes

  1. Change of ULCER AREA

    Time frame: Change from baseline at 9 weeks

    Change from baseline at 9 weeks of the surface area of the ulcer, in cm3, measured using ImageJ software from the weekly the photographs of the wound

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

    Time frame: Change from baseline at 9 weeks

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

  3. REDUCTION IN ULCER SIZE

    Time frame: Change from baseline at 9 weeks

    Difference in the area of the wound between week 9 and the first treatment session.

  4. Change of the CIVIQ SCORE

    Time frame: Change from baseline to 9th week

    change of the scale assessing quality of life of patients with chronic venous insufficiency, considering four dimensions (physical, psychological, social and pain) with a score ranging from 20 to 100, where 20 corresponds to the poorest quality of life and 100 to the best.

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers Compared to Moist Wound Care in a Primary Care Setting

Acronym: PRP-2012

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2013
Registry last updated
Jul 23, 2015

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.

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