UlcerPhase 3PRPULCERASNCT02213952
PRP ULCERAS: Clinical Trial Phase III
A Phase 3 study testing Platelet-Rich Plasma and Usual treatment in people with Ulcer, run by Basque Health Service at 2 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ulcer
- What is being tested?
- Platelet-Rich Plasma and Usual treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
UIAPB
Bilbao, Bizkaia, 48014
Comarca Enkarterri Ezkerraldea
Portugalete, Bizakaia, 48920
About this study
Official title: Efficacy of Autologous Platelet-Rich Plasma in the Treatment of Vascular Ulcers in Primary Care: Clinical Trial Phase III
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".
Read the 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".
- Conditions
- Ulcer
- Being tested
- Platelet-Rich Plasma, Usual treatment
- Keywords
- Ulcer, Platelet-Rich Plasma
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich PlasmaDrug
Also called PRP
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.
Usual treatmentOther
Also called Osakidetza protocol of humid environment cure.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 9 weeks
Secondary outcomes (2)
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).
Measured: Change from baseline at 9 weeks
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
Measured: Change from baseline at 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2017
Why it stopped: Without recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- Osakidetza
- Responsible party
- Principal investigator, Kepa M. San Sebastián Moreno, Basque Health Service
- Investigators
- Kepa Mirena San Sebastian Moreno, Principal investigator, C. Ezkerraldea Enkarterri.Igone Hernández Cabezas., Study chair, C. Ezkerraldea EnkarterriIgone Lobato García, Study chair, C. Ezkerraldea EnkarterriBegoña Rodríguez Rodríguez., Study chair, C. BilbaoAriadna Pérez Salvador, Study chair, C. Ezkerraldea EnkarterriGonzalo Grandes Odriozola, Study chair, Primary Care Research Unit of BizkaiaNatalia Burgos Alonso., Study director, Primary Care Research Unit of BizkaiaAnna Giné March, Study director, Primary Care Research Unit of Bizkaia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213952
- Sponsor's protocol ID
- UIAPB-PRPULCERAS-2014-02
- Other IDs
- 2014-001514-26, 2014
- Acronym
- PRPULCERAS
- Status last verified
- Feb 2020
- First submitted
- 16 Jul 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25547983
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Autologous Platelet-Rich Plasma in the Treatment of Vascular Ulcers in Primary Care: Clinical Trial Phase III
- ClinicalTrials.gov ID
- NCT02213952
- Acronym / sponsor ID
- PRPULCERAS / UIAPB-PRPULCERAS-2014-02
- Conditions
- Ulcer
- Keywords
- Ulcer, Platelet-Rich Plasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Without recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- Osakidetza
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma | Experimental | Drug: Platelet-Rich PlasmaOur 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 | Active comparator | Other: Usual treatmentUsual 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich PlasmaAlso: PRPFor 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. | Drug | Platelet-Rich Plasma |
| Usual treatmentAlso: Osakidetza protocol of humid environment cure.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 |
Primary outcome
ULCER SIZE CHANGE
Time frame: Change from baseline at 9 weeks
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.
2 secondary outcomes
QUALITY OF LIFE (INDEX CIVIQ)
Time frame: Change from baseline at 9 weeks
Change of the percentage OF PATIENTS WITH A ONLY ONE TREATMENT FOR WEEK
Time frame: Change from baseline at 9 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 25547983San 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kepa Mirena San Sebastian Moreno principal investigator
C. Ezkerraldea Enkarterri.
Igone Hernández Cabezas. study chair
C. Ezkerraldea Enkarterri
Igone Lobato García study chair
C. Ezkerraldea Enkarterri
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet-Rich Plasma and Usual treatment in people with Ulcer, run by Basque Health Service at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ULCER SIZE CHANGE (time frame: Change from baseline at 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02213952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.