Varicose UlcerNCT03127904
Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
A study testing Vein Fitness and Compressive therapy and wound care in people with Varicose Ulcer, run by Pró Circulação® at 1 site in Brazil.
Trial summary
The objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Ulcer
- What is being tested?
- Vein Fitness and Compressive therapy and wound care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Jul 2018to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Venous ulcers due to chronic venous disease assessed by color duplex scan (CDS) examination in standing position. Reflux will be assessed using CDS over a longitudinal vein through the manual compression of the calf in a distant position from the examined area. Reflux will be considered pathological if: >0.5 seconds (s) in the superficial venous system, or > 1.0 s in the deep system, or > 0.35 s in a perforator vein.
Who cannot join
- Investigators will exclude patients with ulcers from any other cause, including arterial insufficiency, with ankle-brachial pressure index (ABPI) < 0.8. Also will be excluded patients who use immunosuppressive and chemotherapy drugs, who have allergies to compression materials, and wheelchair users (due to the impossibility of performing the exercises).
Trial locations and contacts
1 site in 1 country.
Clodoaldo A. De Sá, Ph.D. contact
Brazil1 site, 1 recruiting
- Recruiting
Pró-Circulação - Clinic of Angiology and Vascular Surgery
Xanxerê, Santa Catarina, 89.820-000
Eduardo Matta
About this study
Official title: Pragmatic, Bayesian Adaptive Trial Comparing the Venfit System Against Standard Compressive Therapy in the Treatment of Venous Ulcers
The objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. The investigators hypothesized that the combined therapy will have a higher closure rate as well as lower time to closure.
Read the detailed description
This is a Bayesian adaptive, randomized, controlled, parallel, two-armed Bayesian adaptive trial. Patients diagnosed with varicose ulcers through Doppler ultrasonography will be recruited at the Pro Circulation Clinic of Angiology and Vascular Surgery, Brazil. The active group will be the Vein Fitness system, a multimodal intervention comprising exercise, lymphatic drainage, and compressive therapy, while the control group will be standard compressive therapy and regular wound care. The researchers will measure closure of the wounds and the closure rate as the primary outcomes. The study was designed in accordance with the CONSORT statement.
- Conditions
- Varicose Ulcer
- Being tested
- Vein Fitness, Compressive therapy and wound care
- Keywords
- Varicose ulcer, Compressive therapy, Venous ulcer, Chronic venous disease
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein FitnessProcedure or surgery
Vein fitness is a combination of whole-limb exercises, manual lymphatic drainage, and usual care (wound care and compressive therapy).
Compressive therapy and wound careProcedure or surgery
Compressive therapy consists in the application of pressure to the inferior limb. Investigators describe the specifics in the arm section.
As previously described, a trained nurse will be in charge of keeping the wound healthy, verifying the surface is clean, debriding it, and removing biofilm from it.
| Study group | Role | What they receive |
|---|---|---|
| Vein Fitness | Experimental | Lymphomiokinetic exercises will be performed during a 1 hour period, with the patients in a supine position, legs elevated and properly positioned on a carpet; the knees will be mildly flexed to a comfortable point. The patients will put feet on the pedals of ankle extension/flexion device. The frequency will be around 15 to 20 cycles/minute, while the amplitude will be individually adjusted according to the range of movement of each patient. During the exercises, study personnel will manually drain the lower members.
Compressive therapy will be applied as described in the control group arm.
Care of the wound will be delivered as described in the control group arm. Receives: Procedure: Vein Fitness; Procedure: Compressive therapy and wound care |
| Control group | Active comparator | Compressive therapy will be applied to both groups by properly trained personnel. Each layer of the compressive boot will have a 50% overlap, from the base to of the fingers to 3 cm bellow the popliteal fossa. The interface pressure used will be of at least 50mmHg in supine position.
Wound care will be delivered to every individual in both groups, 1 or 2 times each week by a nurse certified in wound management, following the principles of maintenance of a moisturized surface between the wound and its cover. The nurse will also carry out mechanical wound debriding and biofilm removal. Receives: Procedure: Compressive therapy and wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing of venous ulcer.
Healing is defined as having the ulcer fully covered with scarring tissue.
Measured: 3 months
Rate of ulcer closure
A ratio of the ulcer area and the time that it takes to close. Ulcer size will be measured using a standard protocol: First, we will photograph the wounds at a standard one meter distance having a ruler besides the lower extremity. The area of each wound will then be estimated through the Imagej software (National Institutes of Health) using a freehand drawing surrounding its border, with software calibration based on the pre-established dimensions of the background image. We will also assess a subset of 20 images by two independent observers to estimate inter-observer reliability.
Measured: 3 months
Secondary outcomes (11)
Time-to-closure
The time that it takes for an ulcer to close. Ulcer size will be measured using a standard protocol: First, we will photograph the wounds at a standard one meter distance having a ruler besides the lower extremity. The area of each wound will then be estimated through the Imagej software (National Institutes of Health) using a freehand drawing surrounding its border, with software calibration based on the pre-established dimensions of the background image. We will also assess a subset of 20 images by two independent observers to estimate inter-observer reliability.
Measured: 3 months
Ankle range of motion
The angle that the ankle can reach as it moves. We will measure ankle range of motion through a goniometer. Specifically, passive ankle motion will be performed, with the fixed arm of the goniometer located on the leg axis, aligning the movable arm with the foot axis. We will perform all procedures in an office setting by trained physical therapists. A random group of patients will have the goniometry procedure performed twice by two independent physical therapists to assess the inter-observer reliability of these metrics.
Measured: 3 months
Leg strength
The stand-up test will be used to measure the force of the inferior limb
Measured: 3 months
Health-related quality of Life
Heath related quality of life will be assessed with a validated Portuguese version of the SF-36 (Short-Form Health Survey) tool.
Measured: 3 months
Leg perimetry
Perimetry will be conducted at two different levels of the foot, and at five distinct levels of the leg, using a regular commercial tape. No pressure will be applied to these measurements to avoid affecting their precision. We will conduct the first-foot measurement five centimeters proximal to the base of the first proximal phalanx of the second toe, and the second measurement five centimeters proximal to the first measure. The first leg measurement will be performed five centimeters above the inferior border of the lateral malleolus, and then followed at every five centimeters to a total of six to eight measurements depending on the leg height.
Measured: 3 months
Barthel Index
An ordinal scale used to measure performance in activities of daily living (ADL). Ten variables evaluating ADL and mobility are scored. Each item is rated in terms of whether the individual can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. SScores of 0-20 indicate "total" dependency, 21-60 represents "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.
Measured: 3 months
Lawton-Brody Instrumental Activities of Daily Living (iADL)
Used to assess independent living skills of an individual and measures functional ability. Each item is rated trichotomously (1 = unable, 2 = needs assistance, 3 = independent) and the score is the sum of the responses. The higher the score, the greater the person's abilities.
Measured: 3 months
Physical Activity Questionnaire (IPAQ)
IPAQ assesses physical activity undertaken across a comprehensive set of domains, including leisure-time physical activity, domestic and gardening (yard) activities, work-related physical activity, and transport-related physical activity. The score is obtained by the sum of the duration (in minutes) and frequency (days) for all the types of activities in all domains. A higher score represents a higher level of physical activity.
Measured: 3 months
Interface Pressure (IP)
Defined as the pressure exerted by the compression system over the surface of skin.
Measured: 3 months
Static Stiffness Index (SSI)
Defined as the difference between standing and resting pressure
Measured: 3 months
Working Pressure Amplitude (WPA)
Considered as the difference between the lowest and highest interface pressure recorded during flexion and extension movements.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start24 Jul 2018
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pró Circulação®
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Matta, MD, Principal investigator, Pró Circulação®
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127904
- Sponsor's protocol ID
- Procirculacao1
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic, Bayesian Adaptive Trial Comparing the Venfit System Against Standard Compressive Therapy in the Treatment of Venous Ulcers
- ClinicalTrials.gov ID
- NCT03127904
- Acronym / sponsor ID
- Procirculacao1
- Conditions
- Varicose Ulcer
- Keywords
- Varicose ulcer, Compressive therapy, Venous ulcer, Chronic venous disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pró Circulação®University, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Bayesian Adaptive trial is to compare a control group versus a comprehensive ulcer healing protocol. The latter involves a combination of compressive therapy, miokinetic drainage and muscle strengthening for the entire lower extremity pump among patients with lower extremity venous ulcers. The investigators hypothesized that the combined therapy will have a higher closure rate as well as lower time to closure.
Detailed description
This is a Bayesian adaptive, randomized, controlled, parallel, two-armed Bayesian adaptive trial. Patients diagnosed with varicose ulcers through Doppler ultrasonography will be recruited at the Pro Circulation Clinic of Angiology and Vascular Surgery, Brazil. The active group will be the Vein Fitness system, a multimodal intervention comprising exercise, lymphatic drainage, and compressive therapy, while the control group will be standard compressive therapy and regular wound care. The researchers will measure closure of the wounds and the closure rate as the primary outcomes. The study was designed in accordance with the CONSORT statement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vein Fitness | Experimental | Procedure: Vein Fitness, Procedure: Compressive therapy and wound careLymphomiokinetic exercises will be performed during a 1 hour period, with the patients in a supine position, legs elevated and properly positioned on a carpet; the knees will be mildly flexed to a comfortable point. The patients will put feet on the pedals of ankle extension/flexion device. The frequency will be around 15 to 20 cycles/minute, while the amplitude will be individually adjusted according to the range of movement of each patient. During the exercises, study personnel will manually drain the lower members. Compressive therapy will be applied as described in the control group arm. Care of the wound will be delivered as described in the control group arm. |
| Control group | Active comparator | Procedure: Compressive therapy and wound careCompressive therapy will be applied to both groups by properly trained personnel. Each layer of the compressive boot will have a 50% overlap, from the base to of the fingers to 3 cm bellow the popliteal fossa. The interface pressure used will be of at least 50mmHg in supine position. Wound care will be delivered to every individual in both groups, 1 or 2 times each week by a nurse certified in wound management, following the principles of maintenance of a moisturized surface between the wound and its cover. The nurse will also carry out mechanical wound debriding and biofilm removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Venous ulcers due to chronic venous disease assessed by color duplex scan (CDS) examination in standing position. Reflux will be assessed using CDS over a longitudinal vein through the manual compression of the calf in a distant position from the examined area. Reflux will be considered pathological if: >0.5 seconds (s) in the superficial venous system, or > 1.0 s in the deep system, or > 0.35 s in a perforator vein.
Key exclusion criteria (1 listed)
- Investigators will exclude patients with ulcers from any other cause, including arterial insufficiency, with ankle-brachial pressure index (ABPI) < 0.8. Also will be excluded patients who use immunosuppressive and chemotherapy drugs, who have allergies to compression materials, and wheelchair users (due to the impossibility of performing the exercises).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vein FitnessVein fitness is a combination of whole-limb exercises, manual lymphatic drainage, and usual care (wound care and compressive therapy). | Procedure or surgery | Vein Fitness |
| Compressive therapy and wound careCompressive therapy consists in the application of pressure to the inferior limb. Investigators describe the specifics in the arm section. As previously described, a trained nurse will be in charge of keeping the wound healthy, verifying the surface is clean, debriding it, and removing biofilm from it. | Procedure or surgery | Control group, Vein Fitness |
Primary outcome
Healing of venous ulcer.
Time frame: 3 months
Healing is defined as having the ulcer fully covered with scarring tissue.
Rate of ulcer closure
Time frame: 3 months
A ratio of the ulcer area and the time that it takes to close. Ulcer size will be measured using a standard protocol: First, we will photograph the wounds at a standard one meter distance having a ruler besides the lower extremity. The area of each wound will then be estimated through the Imagej software (National Institutes of Health) using a freehand drawing surrounding its border, with software calibration based on the pre-established dimensions of the background image. We will also assess a subset of 20 images by two independent observers to estimate inter-observer reliability.
11 secondary outcomes
Time-to-closure
Time frame: 3 months
Ankle range of motion
Time frame: 3 months
Leg strength
Time frame: 3 months
Health-related quality of Life
Time frame: 3 months
Leg perimetry
Time frame: 3 months
Barthel Index
Time frame: 3 months
Lawton-Brody Instrumental Activities of Daily Living (iADL)
Time frame: 3 months
Physical Activity Questionnaire (IPAQ)
Time frame: 3 months
Interface Pressure (IP)
Time frame: 3 months
Static Stiffness Index (SSI)
Time frame: 3 months
Working Pressure Amplitude (WPA)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Varicose Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clodoaldo A. De Sá, Ph.D. contact
Eduardo Matta, MD principal investigator
Pró Circulação®
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein Fitness and Compressive therapy and wound care in people with Varicose Ulcer, run by Pró Circulação® at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Matta, MD (55 (49) 3433-9050, procirculacao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing of venous ulcer. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.