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

Chronic Ulcer Clinical Trial

— PRP-2012  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817218
• Other study ID #: 2012-002247-20
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 27, 2013
• Last updated: July 22, 2015
• Start date: June 2013
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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 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" .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Ulcer
• Ulcer
• Varicose Ulcer

Intervention

Drug:
• Platelet Rich Plasma

Device:
• Osakidetza protocol
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.

Locations

Country	Name	City	State
Spain	Comarca Enkarterri Ezkerraldea	Portugalete	Bizakaia

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of ULCER AREA	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	Change from baseline at 9 weeks	No
Primary	Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK	Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK	Change from baseline at 9 weeks	No
Primary	REDUCTION IN ULCER SIZE	Difference in the area of the wound between week 9 and the first treatment session.	Change from baseline at 9 weeks	No
Primary	Change of the CIVIQ SCORE	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.	Change from baseline to 9th week	Yes