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Trial registered on ANZCTR


Registration number
ACTRN12615001112550
Ethics application status
Approved
Date submitted
25/03/2015
Date registered
21/10/2015
Date last updated
21/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of platelet-rich plasma in venous ulcer.
Scientific title
Platelet-rich plasma in patients with venous ulcer healing study.
Secondary ID [1] 286410 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous ulcer healing 294567 0
local pain in venous ulcer 294568 0
Condition category
Condition code
Skin 294874 294874 0 0
Dermatological conditions
Cardiovascular 295076 295076 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Platelet rich plasma (PRP) is applied to the wound bed every week during the 24 week intervention period. During each application wound will be cleaned with soapy chlorhexidine and normal saline. PRP is then instilled onto the wound bed using PRGF technique (Registered Trademark) making sure that entire wound bed area is covered. Wound is then covered with Mepitel (Registered Trademark) contact layers followed by new gauze dressing and a single layer of pressure bandage. 72 hours (3 days) and 5 days after each PRP instillation, standard care is administered. Ulcer care and administration of PRP are performed by the principal investigator, a specialist nurse under the supervision of medical specialist in surgery
Intervention code [1] 291481 0
Treatment: Other
Comparator / control treatment
Make standard care each 48 hours: previous cleaning and debridement with saline, covered with saline impregnated gauze and cover with secondary of gauzes and one layer compressive bandage, during 24 weeks. Measure weekly ulcer area and calculate the reduction rate of ulcer at the beginning and after 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 294625 0
% Reduction in ulcer surface area.
Calculated the difference in percentage of the initial surface to the end surface.To calculate the surface of the ulcer of the ellipse formula was used.
A = length x width x 0.675
Timepoint [1] 294625 0
24 weeks after randomization
Primary outcome [2] 294626 0
pain reduction as visual analog pain scale
Timepoint [2] 294626 0
24 weeks after randomization
Secondary outcome [1] 313741 0
Secondary effects after application of platelet-rich plasma.
The side effects are rated local infection and irritative dermatitis. Are valued according to visual inspection of the principal investigator once a week according observation of the following signs: increased exudate, increasing pain, itching, erythema periulcer.
Timepoint [1] 313741 0
Every week for 24 weeks

Eligibility
Key inclusion criteria
-Patient venous ulcer etiology with more than 6 weeks evolution.
-Age, +18 years.
-Unassisted ambulation by others or need to brace for activities of daily living activities.
-Ankle-arm index more than 0.8 and less than 1.2 in the presence of ulcer member.
- Not have undergone surgery for the treatment of venous insufficiency before or during treatment with PRP.
-Tolerance one layer for compressive therapy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Critical thrombocytopenia, definedas aplatelet count 150.000/ul.
- Hemoglobin level below 10g /dl.
-Drug therapy: NSAIDs (7 days), systemic corticosteroids(15 days), immunosuppressants, cytotoxic chemotherapy, antiplatelet and anticoagulation.
-Platelet dysfunction syndrome.
- Hemodynamic instability.
- Autoimmune disease.
- Oncological disease.
-Liver disease.
- Septicemia.
- Poorly controlled diabetes.
- Morbid obesity.
- Renal insufficiency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
For the comparative study between variables the following tests were applied:

Study of the associations between continue quantitative variables:

Normality was studied in the distribution of the sample by testing Kolmorov Smirnov normality and Shapiro Wilk and display data not normally distributed were analyzed using non-parametric U-test of Mann-Whitney.


Studyof correlation between variables:

To analyze the correlation between the evolution of healing and ulcer-related variables the Pearson correlation coefficient was determined by taking meaningful relationships as those having a lower significance of 0.01.
For calculating the sample size is decided to fix the error a 5%, it was decided to assume a beta error of 20%, therefore the study power is 80% (1 - beta).
The sample size is 47 cases obtained in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6770 0
Spain
State/province [1] 6770 0
Sevilla

Funding & Sponsors
Funding source category [1] 290979 0
Hospital
Name [1] 290979 0
District hospital de la Merced de Osuna (Spain).
Address [1] 290979 0
Av. de la Constitucion s/n.
Osuna, (Sevilla) CP 41640
Country [1] 290979 0
Spain
Primary sponsor type
University
Name
School of nursing, physiotherapy and podiatry, University of Sevilla
Address
Avenzoar, 6. CP 41009. Sevilla
Country
Spain
Secondary sponsor category [1] 289658 0
None
Name [1] 289658 0
Address [1] 289658 0
Country [1] 289658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292571 0
Ethics Committee and experimentation of the University of Seville
Ethics committee address [1] 292571 0
Pabellon de Brasil. Paseo de las Delicias s/n. Sevilla. CP 41013
Ethics committee country [1] 292571 0
Spain
Date submitted for ethics approval [1] 292571 0
Approval date [1] 292571 0
05/02/2011
Ethics approval number [1] 292571 0

Summary
Brief summary
The aim of this study is to test the efficacy of platelet-rich plasma on improving healing in venous ulcer and its effect in reducing local pain while also examining occurrence of any possible side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56026 0
Prof Manuel Escamilla Cardenosa
Address 56026 0
Arcipreste Valderrama, 6. Osuna, Sevilla (Spain). CP 41640
University Hospital of Merced in Osuna, Sevilla (Spain).

Country 56026 0
Spain
Phone 56026 0
+34 955820149
Fax 56026 0
Email 56026 0
manuelec@euosuna.org
Contact person for public queries
Name 56027 0
Prof Manuel Escamilla Cardenosa
Address 56027 0
Arcipreste Valderrama, 6. Osuna, Sevilla (Spain). CP 41640
University Hospital of Merced in Osuna, Sevilla (Spain).
Country 56027 0
Spain
Phone 56027 0
+34 955820149
Fax 56027 0
Email 56027 0
manuelec@euosuna.org
Contact person for scientific queries
Name 56028 0
Dr Antonio Cordoba Fernandez
Address 56028 0
Avicena s/n, 41009 Sevilla (Spain)
School of Nursing, Physiotherapy and Podiatry of the university Seville

Country 56028 0
Spain
Phone 56028 0
+34 954486539
Fax 56028 0
fax: +34 954486527
Email 56028 0
acordoba@us.es

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary