Venous UlcersNCT01491438
Plasma Rich Growth Factors in Venous Ulcers
A study testing PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary and Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary in people with Venous Ulcers, run by Basque Health Service at 1 site in Spain.
Trial summary
OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcers
- What is being tested?
- PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary and Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Nov 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years.
- Patients with at least one venous ulcer of at least 6 weeks of evolution.
- Diameter between 0,5-6cm.
Who cannot join
- Cutaneous ulcers with an arterial and/or mixed origin.
- Ankle-arm index <0.9.
- Concomitant terminal disease with bad prognosis.
- Hematologic several abnormalities (anemia with hemoglobin <11g/dl, hematocrit <34%, lymphomas and leukemias).
- Antineoplastic or immunosuppressive treatment.
- Solid tumors.
Show all 9Show fewer
- Nutritional status affectation.
- Known peripheral neuropathy in patients with diabetes mellitus.
- At home patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Determinate the Effectiveness and Safety of Plasma Rich Growth Factors (PRGF) in Venous Ulcers Treatment
OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment.
SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment.
Read more
Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit.
STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.
Read the detailed description
An open, randomized, of parallel groups, and controlled clinical trial. Patients will be allocated on first come to one of the two treatment groups using a block random sequence generated by computer that will remain hidden from the researchers and patients until allocation.
Experimental group: PRGF together with the corresponding dressing according to annex IV.
Control group: Corresponding dressing according to annex IV.
Both groups will be submitted to a cleaning, debridement, occlusive dressing and use of antibiotic if necessary in each visit.
After signing consent form, and previously of randomization, patients will be submitted to a blood extraction where it will be determinate: Albumine (in g/dl), Hemoglobin (in g/dl), Hematocrit (in %), Creatinine (in mg/dl). If patients have data collected through previous analysis performed until 30 days before, it will not be necessary a new extraction.
Patients will be also submitted to an initial valuation of:
- medical antecedents: history of chronic venous insufficiency, previous medical treatments.
- general state: dependence grade through Barthel index, mobility, ankle arm index.
- ulcer characteristics:exudate, sing of location of ulcer, antiquity of ulcer, tunneling,infection, pain through a Visual Analogue Scale (VAS).
- Anthropometric characteristics; Weight, height and Body Mass Index (BMI).
Patients will go to the physician's consult every fours days (on Monday or Tuesday and Thursday or Friday). When one ulcer is closed, patient will go to physician's consult to confirm that it remains closed at seven and fifteen days.
In both intervention and control groups, the bad evolution of ulcer with deterioration at least during four consecutive weeks, will obligate to ask a preferred inter-consultation with Vascular Surgery Service.
In each visit the following variables will be measured:
- Wound surface (in cm2) measured through PUSH scale (Pressure Ulcer Scale for Healing) belonging to GNEAUPP group (National Group to study and advice about pressure ulcers and chronic wounds). This variable will be measured in each visit.
- Safety variable: Pruritus (Yes/No), Pain (through VAS scale), Sings of infection (Yes/No).
If patient experience one adverse effect which according to judgment of nurse precludes its continuation into the study, the nurse will communicate it to physician who will discharge from study if it is necessary.
All this will be collected in Case Report Form (CRF).
- Conditions
- Venous Ulcers
- Being tested
- PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary, Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessaryProcedure or surgery
PRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4)during 12 weeks.
Types of dressing: enzyme cutting dressing (collagenase), hydrogel, polymeric foam, alginate dressing, hydrocolloid hydrofiber dressing, silver dressing, coal and silver dressing, argentum sulfadiazine dressing, polyurethane or caster hydrocolloid dressing
Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessaryProcedure or surgery
Twice a week (days 1 and 4) during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| PRGF and conventional treatment | Experimental | PRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4) Receives: Procedure: PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary |
| Conventional treatment alone | Active comparator | Conventional treatment (cleaning, debridement of the wound and application of the corresponding dressing and using of antibiotics if necessary) twice a week (days 1 and 4). Receives: Procedure: Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcers closed
Patients will be followed during 12 weeks.
Measured: at 12 weeks of treatment
Secondary outcomes (4)
Pruritus (Yes/No)
Measured: During 12 weeks of treatment (in each visit)
Pain (through VAS scale)
Measured: During 12 weeks of treatment (in each visit)
Signs of infection (Yes/No)
Measured: During 12 weeks of treatment (in each visit)
Wound surface (in cm2) measured through PUSH scale
Measured: Every 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startNov 2013
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Javier Urraca García de Madinabeitia, Basque Health Service
- Investigators
- Javier Urraca, Principal investigator, Basque Public Health Service-Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491438
- Sponsor's protocol ID
- ULC01
- Status last verified
- Dec 2011
- First submitted
- 7 Dec 2011
- Last updated
- 7 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Determinate the Effectiveness and Safety of Plasma Rich Growth Factors (PRGF) in Venous Ulcers Treatment
- ClinicalTrials.gov ID
- NCT01491438
- Acronym / sponsor ID
- ULC01
- Conditions
- Venous Ulcers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 14 Dec 2011 (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.
OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment.
SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment.
Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit.
STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.
Detailed description
An open, randomized, of parallel groups, and controlled clinical trial. Patients will be allocated on first come to one of the two treatment groups using a block random sequence generated by computer that will remain hidden from the researchers and patients until allocation.
Experimental group: PRGF together with the corresponding dressing according to annex IV.
Control group: Corresponding dressing according to annex IV.
Both groups will be submitted to a cleaning, debridement, occlusive dressing and use of antibiotic if necessary in each visit.
After signing consent form, and previously of randomization, patients will be submitted to a blood extraction where it will be determinate: Albumine (in g/dl), Hemoglobin (in g/dl), Hematocrit (in %), Creatinine (in mg/dl). If patients have data collected through previous analysis performed until 30 days before, it will not be necessary a new extraction.
Patients will be also submitted to an initial valuation of:
- medical antecedents: history of chronic venous insufficiency, previous medical treatments.
- general state: dependence grade through Barthel index, mobility, ankle arm index.
- ulcer characteristics:exudate, sing of location of ulcer, antiquity of ulcer, tunneling,infection, pain through a Visual Analogue Scale (VAS).
- Anthropometric characteristics; Weight, height and Body Mass Index (BMI).
Patients will go to the physician's consult every fours days (on Monday or Tuesday and Thursday or Friday). When one ulcer is closed, patient will go to physician's consult to confirm that it remains closed at seven and fifteen days.
In both intervention and control groups, the bad evolution of ulcer with deterioration at least during four consecutive weeks, will obligate to ask a preferred inter-consultation with Vascular Surgery Service.
In each visit the following variables will be measured:
- Wound surface (in cm2) measured through PUSH scale (Pressure Ulcer Scale for Healing) belonging to GNEAUPP group (National Group to study and advice about pressure ulcers and chronic wounds). This variable will be measured in each visit.
- Safety variable: Pruritus (Yes/No), Pain (through VAS scale), Sings of infection (Yes/No).
If patient experience one adverse effect which according to judgment of nurse precludes its continuation into the study, the nurse will communicate it to physician who will discharge from study if it is necessary.
All this will be collected in Case Report Form (CRF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRGF and conventional treatment | Experimental | Procedure: PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessaryPRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4) |
| Conventional treatment alone | Active comparator | Procedure: Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessaryConventional treatment (cleaning, debridement of the wound and application of the corresponding dressing and using of antibiotics if necessary) twice a week (days 1 and 4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Older than 18 years.
- Patients with at least one venous ulcer of at least 6 weeks of evolution.
- Diameter between 0,5-6cm.
Key exclusion criteria (9 listed)
- Cutaneous ulcers with an arterial and/or mixed origin.
- Ankle-arm index <0.9.
- Concomitant terminal disease with bad prognosis.
- Hematologic several abnormalities (anemia with hemoglobin <11g/dl, hematocrit <34%, lymphomas and leukemias).
- Antineoplastic or immunosuppressive treatment.
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 |
|---|---|---|
| PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessaryPRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4)during 12 weeks. Types of dressing: enzyme cutting dressing (collagenase), hydrogel, polymeric foam, alginate dressing, hydrocolloid hydrofiber dressing, silver dressing, coal and silver dressing, argentum sulfadiazine dressing, polyurethane or caster hydrocolloid dressing | Procedure or surgery | PRGF and conventional treatment |
| Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessaryTwice a week (days 1 and 4) during 12 weeks | Procedure or surgery | Conventional treatment alone |
Primary outcome
Ulcers closed
Time frame: at 12 weeks of treatment
Patients will be followed during 12 weeks.
4 secondary outcomes
Pruritus (Yes/No)
Time frame: During 12 weeks of treatment (in each visit)
Pain (through VAS scale)
Time frame: During 12 weeks of treatment (in each visit)
Signs of infection (Yes/No)
Time frame: During 12 weeks of treatment (in each visit)
Wound surface (in cm2) measured through PUSH scale
Time frame: Every 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
Related trials for Venous Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
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.
Javier Urraca principal investigator
Basque Public Health Service-Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary and Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary in people with Venous Ulcers, 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 3 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: status not confirmed, as of the sponsor's last update on 7 Feb 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Urraca (945006669, JAVIER.URRACAGARCIAMADINABEITIA@osakidetza.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcers closed (time frame: at 12 weeks of treatment). 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 7 Feb 2013.