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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
Type of registration
Retrospectively registered
Titles & IDs
Public title
Radio electric asymmetric conveyer (REAC) technology effects on venous ulcers and wound healing
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Scientific title
REAC technology effects on wound healing, pain and psychosocial aspects in venous ulcers. A randomized controlled study.
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Secondary ID [1]
288582
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous ulcers
297716
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Condition category
Condition code
Skin
297900
297900
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0
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Other skin conditions
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Cardiovascular
298833
298833
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
293971
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Treatment: Devices
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Intervention code [2]
293972
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Prevention
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Comparator / control treatment
Group B will be treated with standard dressing + elastic compression once a week until healing
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Control group
Active
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Outcomes
Primary outcome [1]
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Outcome:Healing.
Specific tool: Software for monitoring the ulcers evolution.
Assesment of the outcome: Size of ulcer as monitored by imaging software
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Assessment method [1]
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Timepoint [1]
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Baseline and every 2 weeks during the treatment until healed
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Primary outcome [2]
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For the evaluation of pain symptom, we will use a visual analogue scale (VAS).
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Assessment method [2]
297421
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Timepoint [2]
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Every 2 weeks during the treatment until healed
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Secondary outcome [1]
320993
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For the evaluation of the quality of life,we will use a the Civic 20 Q test
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Assessment method [1]
320993
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Timepoint [1]
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Every 2 weeks during the treatment until healed
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Eligibility
Key inclusion criteria
Presence of venous ulcers, no signs of intolerance or allergy to constituents of the products used.
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Minimum age
30
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
5/01/2015
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Date of last participant enrolment
Anticipated
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Actual
28/04/2018
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Date of last data collection
Anticipated
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Actual
19/10/2018
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Sample size
Target
60
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Accrual to date
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Final
60
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Recruitment outside Australia
Country [1]
7606
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Italy
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State/province [1]
7606
0
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Country [2]
7607
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San Marino
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State/province [2]
7607
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Funding & Sponsors
Funding source category [1]
292930
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Charities/Societies/Foundations
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Name [1]
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Rinaldi Fontani Foundation
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Address [1]
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Viale Belfiore 43, 50144 Firenze
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Country [1]
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Italy
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Primary sponsor type
Charities/Societies/Foundations
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Name
Rinaldi Fontani Institute
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Address
Viale Belfiore 43, 50144 Firenze
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Country
Italy
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Secondary sponsor category [1]
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University
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Name [1]
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Interuniversity Center of Phlebolymphology, University of Magna Graecia Catanzaro,
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Address [1]
291689
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Viale Europa, 88100 Catanzaro
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Country [1]
291689
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Italy
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
294439
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Institutional Review Board – Independent Ethics Committee (IRB-IEC) of Interuniversity Center of Phlebolymphology (CIFL)
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Ethics committee address [1]
294439
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Universita Magna Graecia di Catanzaro – Edificio Clinico – Padiglione A- livello II – locali 15-21-23 - Viale Europa – 88100 Catanzaro
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Ethics committee country [1]
294439
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Italy
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Date submitted for ethics approval [1]
294439
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29/08/2013
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Approval date [1]
294439
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04/09/2013
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Ethics approval number [1]
294439
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ER.ALL.2013.22.A
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Salvatore Rinaldi
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Address
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Rinaldi Fontani Institute
Viale Belfiore 43, 50144 Firenze
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Country
63698
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Italy
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Phone
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+39055290307
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Fax
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Email
63698
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[email protected]
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Contact person for public queries
Name
63699
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Salvatore Rinaldi
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Address
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Rinaldi Fontani Institute
Viale Belfiore 43, 50144 Firenze
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Country
63699
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Italy
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Phone
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+39055290307
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Fax
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Email
63699
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[email protected]
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Contact person for scientific queries
Name
63700
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Vania Fontani
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Address
63700
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Rinaldi Fontani Institute
Viale Belfiore 43, 50144 Firenze
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Country
63700
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Italy
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Phone
63700
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+39055290307
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Fax
63700
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Email
63700
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
590
Ethical approval
370160-(Uploaded-03-12-2018-07-05-06)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF