Chronic UlcerPhase 1/2PRP-2012NCT01817218
Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers
A Phase 1/2 study testing Platelet Rich Plasma and Osakidetza protocol in people with Chronic Ulcer, run by Basque Health Service at 1 site 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
- Chronic Ulcer
- What is being tested?
- Platelet Rich Plasma and Osakidetza protocol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Apr 2015
- Phase
- Phase 1/2
- 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 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant women
- Patients with active cellulitis or fever
- An ABI of less than 0.8 or more than 1.5.
Trial locations and contacts
1 site in 1 country.
About this study
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
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" .
- Conditions
- Chronic Ulcer
- Being tested
- Platelet Rich Plasma, Osakidetza protocol
- Keywords
- PRP, chronic vascular ulcer, primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaDrug
Osakidetza protocolDevice
Also called "Antimicrobial debridin", "hydrocolloids", "alginates and hydrofibres", "polyurethane foams"
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP (Platelet Rich Plasma) | Experimental | PRP treatment of vascular ulcers one a week PRP: a volume of 9-30 ml of blood will be collected from the patient (depending of the size of their ulcer) in sterile 4.5-ml tubes containing 3.8% sodium citrate, which will bind to the calcium ions, preventing clot formation we will add 50 μl of CaCl2 per ml liquid plasma. The extraction of the PRP fraction by sticking with a syringe and the adding of CaCl2 should be performed under sterile conditions. Receives: Drug: Platelet Rich Plasma |
| Osakidetza protocol | Active comparator | 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. Receives: Device: Osakidetza protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
REDUCTION IN ULCER SIZE
Difference in the area of the wound between week 9 and the first treatment session.
Measured: Change from baseline at 9 weeks
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.
Measured: Change from baseline to 9th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kepa M. San Sebastián Moreno, Basque Health Service
- Investigators
- Kepa Mirena San Sebastian Moreno, Doctor, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817218
- Sponsor's protocol ID
- 2012-002247-20
- Acronym
- PRP-2012
- Status last verified
- Jul 2015
- First submitted
- 27 Feb 2013
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01817218
- Acronym / sponsor ID
- PRP-2012 / 2012-002247-20
- Conditions
- Chronic Ulcer
- Keywords
- PRP, chronic vascular ulcer, primary care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Jun 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Mar 2013 (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 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" .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP (Platelet Rich Plasma) | Experimental | Drug: Platelet Rich PlasmaPRP treatment of vascular ulcers one a week PRP: a volume of 9-30 ml of blood will be collected from the patient (depending of the size of their ulcer) in sterile 4.5-ml tubes containing 3.8% sodium citrate, which will bind to the calcium ions, preventing clot formation we will add 50 μl of CaCl2 per ml liquid plasma. The extraction of the PRP fraction by sticking with a syringe and the adding of CaCl2 should be performed under sterile conditions. |
| Osakidetza protocol | Active comparator | Device: Osakidetza protocolPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 Plasma | Drug | PRP (Platelet Rich Plasma) |
| Osakidetza protocolAlso: "Antimicrobial debridin", "hydrocolloids", "alginates and hydrofibres", "polyurethane foams"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. | Device | Osakidetza protocol |
Primary outcome
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
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
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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, Doctor principal investigator
Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet Rich Plasma and Osakidetza protocol in people with Chronic Ulcer, run by Basque Health Service at 1 site 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 9 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: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of ULCER AREA (time frame: Change from baseline at 9 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2015.