Plasma Rich Growth Factors in Venous Ulcers
Information source: Basque Health Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Venous Ulcers
Intervention: PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary (Procedure); Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary (Procedure)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Basque Health Service Official(s) and/or principal investigator(s): Javier Urraca, Principal Investigator, Affiliation: Basque Public Health Service-Osakidetza
Overall contact: Javier Urraca, Phone: 945006669, Email: JAVIER.URRACAGARCIAMADINABEITIA@osakidetza.net
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.
Clinical Details
Official title: Randomized Clinical Trial to Determinate the Effectiveness and Safety of Plasma Rich Growth Factors (PRGF) in Venous Ulcers Treatment
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Ulcers closed
Secondary outcome: Pruritus (Yes/No)Pain (through VAS scale) Signs of infection (Yes/No) Wound surface (in cm2) measured through PUSH scale
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Javier Urraca, Phone: 945006669, Email: JAVIER.URRACAGARCIAMADINABEITIA@osakidetza.net
Javier Urraca García de Madinabeitia, Vitoria-Gasteiz, Álava, Spain
Additional Information
Starting date: November 2013
Last updated: February 6, 2013
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