PRP ULCERAS: Clinical Trial Phase III - Clinical Trial for Ulcer | NCT02213952

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Primary Purpose

Status

Withdrawn

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Platelet-Rich Plasma

Usual treatment

About this trial

This is an interventional treatment trial for Ulcer focused on measuring Ulcer, Platelet-Rich Plasma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Comarca Enkarterri Ezkerraldea
UIAPB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet-Rich Plasma

Usual treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

QUALITY OF LIFE (INDEX CIVIQ)

Change of the CIVIQ SCORE. 20-item self-reported quality of life questionnaire scale called Chronic Venous disease quality of life Questionnaire-20 (CIVIQ-20) was created and validated in France in 1996,1 as a sensitive instrument to capture the key dimensions of quality of life (QoL) specifically impaired by chronic venous disease (CVD). Four dimensions of the CIVIQ-20 were identified: physical (4 items), psychological (9 items), social (3 items), and pain (4 items).

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

Full Information

NCT ID

NCT02213952

First Posted

July 16, 2014

Last Updated

February 21, 2020

Sponsor

Basque Health Service

Collaborators

Osakidetza

1. Study Identification

Unique Protocol Identification Number

NCT02213952

Brief Title

PRP ULCERAS: Clinical Trial Phase III

Acronym

PRPULCERAS

Official Title

Efficacy of Autologous Platelet-Rich Plasma in the Treatment of Vascular Ulcers in Primary Care: Clinical Trial Phase III

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Without recruitment

Study Start Date

January 2015 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Basque Health Service

Collaborators

Osakidetza

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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".

Detailed Description

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.The aim of this study is to 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). It is a study which will consist in a randomized clinical test, multicentered, in parallel groups and opened 150 patients suffering of venous vascular ulcers will be studied. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area change", "CIVIQ index", "% one cure per week".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcer

Keywords

Ulcer, Platelet-Rich Plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Platelet-Rich Plasma

Arm Type

Experimental

Arm Description

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.

Arm Title

Usual treatment

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Platelet-Rich Plasma

Other Intervention Name(s)

PRP

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Usual treatment

Other Intervention Name(s)

Osakidetza protocol of humid environment cure.

Intervention Description

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.

Primary Outcome Measure Information:

Title

ULCER SIZE CHANGE

Description

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.

Time Frame

Change from baseline at 9 weeks

Secondary Outcome Measure Information:

Title

QUALITY OF LIFE (INDEX CIVIQ)

Description

Change of the CIVIQ SCORE. 20-item self-reported quality of life questionnaire scale called Chronic Venous disease quality of life Questionnaire-20 (CIVIQ-20) was created and validated in France in 1996,1 as a sensitive instrument to capture the key dimensions of quality of life (QoL) specifically impaired by chronic venous disease (CVD). Four dimensions of the CIVIQ-20 were identified: physical (4 items), psychological (9 items), social (3 items), and pain (4 items).

Time Frame

Change from baseline at 9 weeks

Title

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

Description

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

Time Frame

Change from baseline at 9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials: