Back to resultsVein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
Primary Purpose
Varicose Ulcer
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Vein Fitness
Compressive therapy and wound care
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Ulcer focused on measuring Varicose ulcer, Compressive therapy, Venous ulcer, Chronic venous disease
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Pró-Circulação - Clinic of Angiology and Vascular SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vein Fitness
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Healing of venous ulcer.
Healing is defined as having the ulcer fully covered with scarring tissue.
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.
Secondary Outcome Measures
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.
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.
Leg strength
The stand-up test will be used to measure the force of the inferior limb
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.
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.
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.
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.
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.
Interface Pressure (IP)
Defined as the pressure exerted by the compression system over the surface of skin.
Static Stiffness Index (SSI)
Defined as the difference between standing and resting pressure
Working Pressure Amplitude (WPA)
Considered as the difference between the lowest and highest interface pressure recorded during flexion and extension movements.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03127904
Brief Title
Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
Official Title
Pragmatic, Bayesian Adaptive Trial Comparing the Venfit System Against Standard Compressive Therapy in the Treatment of Venous Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2018 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pró Circulação®
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Ulcer
Keywords
Varicose ulcer, Compressive therapy, Venous ulcer, Chronic venous disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Outcome evaluators and data scientists will be blinded regarding randomization. Blinding will be ensured by asking investigators at the end of the trial if investigators knew the arm to which each subject was going to be allocated prior to opening the envelope.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vein Fitness
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vein Fitness
Intervention Description
Vein fitness is a combination of whole-limb exercises, manual lymphatic drainage, and usual care (wound care and compressive therapy).
Intervention Type
Procedure
Intervention Name(s)
Compressive therapy and wound care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Healing of venous ulcer.
Description
Healing is defined as having the ulcer fully covered with scarring tissue.
Time Frame
3 months
Title
Rate of ulcer closure
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Time-to-closure
Description
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.
Time Frame
3 months
Title
Ankle range of motion
Description
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.
Time Frame
3 months
Title
Leg strength
Description
The stand-up test will be used to measure the force of the inferior limb
Time Frame
3 months
Title
Health-related quality of Life
Description
Heath related quality of life will be assessed with a validated Portuguese version of the SF-36 (Short-Form Health Survey) tool.
Time Frame
3 months
Title
Leg perimetry
Description
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.
Time Frame
3 months
Title
Barthel Index
Description
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.
Time Frame
3 months
Title
Lawton-Brody Instrumental Activities of Daily Living (iADL)
Description
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.
Time Frame
3 months
Title
Physical Activity Questionnaire (IPAQ)
Description
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.
Time Frame
3 months
Title
Interface Pressure (IP)
Description
Defined as the pressure exerted by the compression system over the surface of skin.
Time Frame
3 months
Title
Static Stiffness Index (SSI)
Description
Defined as the difference between standing and resting pressure
Time Frame
3 months
Title
Working Pressure Amplitude (WPA)
Description
Considered as the difference between the lowest and highest interface pressure recorded during flexion and extension movements.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduardo Matta, MD
Phone
55 (49) 3433-9050
Email
procirculacao@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Clodoaldo A. De Sá, Ph.D.
Phone
55 (49) 3321-8215
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Matta, MD
Organizational Affiliation
Pró Circulação®
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pró-Circulação - Clinic of Angiology and Vascular Surgery
City
Xanxerê
State/Province
Santa Catarina
ZIP/Postal Code
89.820-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Matta
12. IPD Sharing Statement
Plan to Share IPD
No
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Vein Fitness System vs Compressive Therapy for Venous Ulcers: a Bayesian Adaptive Trial
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