Plasma Rich Growth Factors in Venous Ulcers
Primary Purpose
Venous Ulcers
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional treatment trial for Venous Ulcers
Eligibility Criteria
Inclusion Criteria:
- Older than 18 years.
- Patients with at least one venous ulcer of at least 6 weeks of evolution.
- Diameter between 0,5-6cm.
Exclusion Criteria:
- 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.
- Nutritional status affectation.
- Known peripheral neuropathy in patients with diabetes mellitus.
- At home patient.
Sites / Locations
- Javier Urraca García de Madinabeitia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PRGF and conventional treatment
Conventional treatment alone
Arm Description
PRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4)
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).
Outcomes
Primary Outcome Measures
Ulcers closed
Patients will be followed during 12 weeks.
Secondary Outcome Measures
Pruritus (Yes/No)
Pain (through VAS scale)
Signs of infection (Yes/No)
Wound surface (in cm2) measured through PUSH scale
Full Information
NCT ID
NCT01491438
First Posted
December 7, 2011
Last Updated
February 6, 2013
Sponsor
Basque Health Service
1. Study Identification
Unique Protocol Identification Number
NCT01491438
Brief Title
Plasma Rich Growth Factors in Venous Ulcers
Official Title
Randomized Clinical Trial to Determinate the Effectiveness and Safety of Plasma Rich Growth Factors (PRGF) in Venous Ulcers Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service
4. Oversight
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PRGF and conventional treatment
Arm Type
Experimental
Arm Description
PRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4)
Arm Title
Conventional treatment alone
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary
Intervention Description
Twice a week (days 1 and 4) during 12 weeks
Primary Outcome Measure Information:
Title
Ulcers closed
Description
Patients will be followed during 12 weeks.
Time Frame
at 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Pruritus (Yes/No)
Time Frame
During 12 weeks of treatment (in each visit)
Title
Pain (through VAS scale)
Time Frame
During 12 weeks of treatment (in each visit)
Title
Signs of infection (Yes/No)
Time Frame
During 12 weeks of treatment (in each visit)
Title
Wound surface (in cm2) measured through PUSH scale
Time Frame
Every 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older than 18 years.
Patients with at least one venous ulcer of at least 6 weeks of evolution.
Diameter between 0,5-6cm.
Exclusion Criteria:
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.
Nutritional status affectation.
Known peripheral neuropathy in patients with diabetes mellitus.
At home patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Javier Urraca
Phone
945006669
Email
JAVIER.URRACAGARCIAMADINABEITIA@osakidetza.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Urraca
Organizational Affiliation
Basque Public Health Service-Osakidetza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Javier Urraca García de Madinabeitia
City
Vitoria-Gasteiz
State/Province
Álava
Country
Spain
12. IPD Sharing Statement
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Plasma Rich Growth Factors in Venous Ulcers
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