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Trial registered on ANZCTR


Registration number
ACTRN12616000698471
Ethics application status
Approved
Date submitted
19/02/2016
Date registered
26/05/2016
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
3/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Radio electric asymmetric conveyer (REAC) technology effects on venous ulcers and wound healing
Scientific title
REAC technology effects on wound healing, pain and psychosocial aspects in venous ulcers. A randomized controlled study.
Secondary ID [1] 288582 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous ulcers 297716 0
Condition category
Condition code
Skin 297900 297900 0 0
Other skin conditions
Cardiovascular 298833 298833 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The venous ulcer is a chronic skin lesion that does not tend to heal spontaneously, has no re epithelialization before 6 weeks and has a high frequency of recurrence. Since the venous ulcer is a chronic condition, characterized by the slow repair and by the tendency to recur, the goal of a therapy is to speed healing time, and improving the quality of life. In this study, we will use the Radio Electric Asymmetric Conveyer (REAC) technology, since it has already proved its efficacy in reparative and regenerative processes even at the cellular level. The REAC Tissue optimization - reparative (TO-RPR) treatment is administered by covering the area to be treated with a special laminar aluminum probe, which constitutes the asymmetric conveyer probe (ACP), connected to the REAC device.
The REAC TO-RPR treatment used in this study has these features: radio frequency emission: 2.4 GHz; emission power <2mW; electric field intensity 0.1 volt/m +/- 20%; number of pulses 200 in 15 minutes of treatment; duty cycle 12.5%. The intervention will be administered by a medical doctor specialized in Phlebolymphology.
This treatment will be administered once a week, according to the replacement of dressings. REAC TO-RPR is safe, painless, non-invasive and free of adverse effects. The REAC model device used in this study is B.E.N.E (ASMED, Florence, Italy).
Patients will be treated also with standard dressing, that consists in cleansing with physiological solution, dressing with gauze impregnated with hyaluronic acid, overlapping 10 x10 folded gauze. After dressing, they will be treated with elastic compression, that consists of multi-layer compression bandaging with skinsaver bandage and cohesive overlaid. The treatments will be carried out until healing.
Intervention code [1] 293971 0
Treatment: Devices
Intervention code [2] 293972 0
Prevention
Comparator / control treatment
Group B will be treated with standard dressing + elastic compression once a week until healing
Control group
Active

Outcomes
Primary outcome [1] 297420 0
Outcome:Healing.
Specific tool: Software for monitoring the ulcers evolution.
Assesment of the outcome: Size of ulcer as monitored by imaging software
Timepoint [1] 297420 0
Baseline and every 2 weeks during the treatment until healed
Primary outcome [2] 297421 0
For the evaluation of pain symptom, we will use a visual analogue scale (VAS).
Timepoint [2] 297421 0
Every 2 weeks during the treatment until healed
Secondary outcome [1] 320993 0
For the evaluation of the quality of life,we will use a the Civic 20 Q test
Timepoint [1] 320993 0
Every 2 weeks during the treatment until healed

Eligibility
Key inclusion criteria
Presence of venous ulcers, no signs of intolerance or allergy to constituents of the products used.
Minimum age
30 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age under 18 years; antibiotics, antifungal, antiviral or chemotherapy in place; pregnancy; immunosuppressive therapy ongoing or planned in the study period; surgeries scheduled in the study period; immune system diseases; life expectancy less than 6 months; systemic infections in place; moderate or severe cognitive impairment.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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] 7606 0
Italy
State/province [1] 7606 0
Country [2] 7607 0
San Marino
State/province [2] 7607 0

Funding & Sponsors
Funding source category [1] 292930 0
Charities/Societies/Foundations
Name [1] 292930 0
Rinaldi Fontani Foundation
Address [1] 292930 0
Viale Belfiore 43, 50144 Firenze
Country [1] 292930 0
Italy
Primary sponsor type
Charities/Societies/Foundations
Name
Rinaldi Fontani Institute
Address
Viale Belfiore 43, 50144 Firenze
Country
Italy
Secondary sponsor category [1] 291689 0
University
Name [1] 291689 0
Interuniversity Center of Phlebolymphology, University of Magna Graecia Catanzaro,
Address [1] 291689 0
Viale Europa, 88100 Catanzaro
Country [1] 291689 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294439 0
Institutional Review Board – Independent Ethics Committee (IRB-IEC) of Interuniversity Center of Phlebolymphology (CIFL)
Ethics committee address [1] 294439 0
Universita Magna Graecia di Catanzaro – Edificio Clinico – Padiglione A- livello II
– locali 15-21-23 - Viale Europa – 88100 Catanzaro
Ethics committee country [1] 294439 0
Italy
Date submitted for ethics approval [1] 294439 0
29/08/2013
Approval date [1] 294439 0
04/09/2013
Ethics approval number [1] 294439 0
ER.ALL.2013.22.A

Summary
Brief summary
The venous ulcer is a chronic skin lesion that does not tend to heal spontaneously, has no re epithelialization before 6 weeks and has a high frequency of recurrence. For this reason, research is studying new methods that can accelerate the healing process. In this scenario, the REAC technology is a regenerative medicine technology that can be useful in promoting the healing process.
The purpose of this study is to verify whether the REAC treatment can speed up the healing process of venous leg ulcers, reducing pain and improving the patient's quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63698 0
Dr Salvatore Rinaldi
Address 63698 0
Rinaldi Fontani Institute
Viale Belfiore 43, 50144 Firenze
Country 63698 0
Italy
Phone 63698 0
+39055290307
Fax 63698 0
Email 63698 0
srinaldi@irf.it
Contact person for public queries
Name 63699 0
Dr Salvatore Rinaldi
Address 63699 0
Rinaldi Fontani Institute
Viale Belfiore 43, 50144 Firenze
Country 63699 0
Italy
Phone 63699 0
+39055290307
Fax 63699 0
Email 63699 0
srinaldi@irf.it
Contact person for scientific queries
Name 63700 0
Dr Vania Fontani
Address 63700 0
Rinaldi Fontani Institute
Viale Belfiore 43, 50144 Firenze
Country 63700 0
Italy
Phone 63700 0
+39055290307
Fax 63700 0
Email 63700 0
vfontani@irf.it

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 590 0
Ethical approval
Citation [1] 590 0
Link [1] 590 0
Email [1] 590 0
Other [1] 590 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary