- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02680834
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
February 11, 2020 updated by: Tactile Medical
Randomized Trial Comparing a Dual Action Pneumatic Compression System Against Multi-Layer Bandaging Systems: A Non-Inferiority Study
The purpose of the study is to test non-inferiority of chronic Venous Leg Ulcer (VLU) area reduction at 16 weeks with a dual action pneumatic compression device compared to multi-layer bandaging.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Participants with a chronic venous leg ulcer will participate in a 2 week run in phase using standard of care multi-layer bandaging before being randomly assigned to either treatment using a dual action pneumatic compression device or continued multi-layer bandaging for up to 16 weeks.
Participants will be seen in clinic for treatment and evaluation of symptoms and quality of life.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85012
- Phoenix VA Health Care System
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Phoenix, Arizona, United States, 85015
- Associated Foot and Ankle Specialists, LLC
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Tucson, Arizona, United States, 85710
- Arizona Regional Medical Research
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California
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Carlsbad, California, United States, 92009
- ILD Research Center
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Fresno, California, United States, 93720
- Limb Preservation Platform - Northwest
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Fresno, California, United States, 93721
- Limb Preservation Platform - Downtown
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Long Beach, California, United States, 90822
- Long Beach VA Healthcare System
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Los Angeles, California, United States, 90024
- UCLA Medical Center
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Los Angeles, California, United States, 90073
- Greater Los Angeles VA Healthcare System
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San Diego, California, United States, 92161
- VA San Diego Healthcare System
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Sylmar, California, United States, 91342
- Olive View - UCLA Medical Center
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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North Miami Beach, Florida, United States, 33169
- Barry University Clinical Research
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South Miami, Florida, United States, 33143
- Foot and Ankle Institute of South Florida
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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New York
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Stony Brook, New York, United States, 11794
- Stony Brook University
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC School of Medicine
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Ohio
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Toledo, Ohio, United States, 43606
- Jobst Vascular Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject must be ≥ 18 years of age or legal age at the time of enrollment.
- Chronic venous insufficiency confirmed by ultrasound within previous 12 months or prior to randomization: if subject had bilateral CVI, the limb that possessed the largest ulcer meeting study criteria was used as the study treatment limb for evaluation and documentation throughout the study. Non-study limbs received standard of care treatment as determined by the treating clinician.
- Must have at least one of the following within the past six (6) months: Dorsalis Pedis (DP) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Posterior Tibial (PT) systolic pressure ≥ 80mmHg for diabetic patients or ≥ 60mmHg for non-diabetic patients on study limb; Transcutaneous partial pressure oxygen (TcP02) > 30mmHg; Great toe systolic pressure > 40mmHg.
- Active ulceration (CEAP classification of C6): VLU was defined by open skin lesion of the leg or foot that occurred in an area affected by venous hypertension.
- Ulcer duration: Non healing VLU ≥ 1 month but not greater than 24 months.
- Ulcer size ≥ 2cm² ≤ 50cm²: if there were multiple ulcers on the study limb, the largest ulcer was used as the study treatment ulcer for evaluation and documentation throughout the study. If two ulcers were separated by no more than one centimeter of normal skin, their areas were added together for study purposes.
- Three or fewer separate full thickness ulcers on the study limb: sum of the ulcer areas on the study limb must be ≤ 50 cm².
- Leg circumferences within the following range: Ankle - 12 to 44cm; Calf - 22 to 60cm; Below knee - 22 to 68cm.
- Able and willing to provide informed consent prior to study participation.
Exclusion Criteria:
- Target ulcer or any other ulcer on the study limb involves exposure of tendon, muscle, or bone.
- Target ulcer was of non-venous etiology (sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma, malignancy).
- Treatment of the target ulcer with living cellular therapy within 30 days of the time of projected randomization.
- Endovenous ablation or other venous surgery within two weeks of enrollment: venous ultrasound must be completed after procedure to determine whether there is still venous insufficiency at the time of enrollment.
- History of skin sensitivity to any of the components of ACT, multi-layer bandages of compression garments.
- History of an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last three (3) months.
- Acute thrombophlebitis within the last six (6) weeks.
- History of pulmonary edema or decompensated congestive heart failure within six (6) weeks of screening.
- Currently has an active infection of the skin on the target limb such as cellulitis requiring antibiotics.
- History of target limb cancer within the last 2 years with the exception of treated non-melanoma skin cancer unless ulcer biopsy performed at screening is negative for neoplasia.
- Active cancer receiving chemotherapy and/or radiation therapy.
- Poorly controlled diabetes with an HbA1c value of > 12% within the past three (3) months.
- Changes to medications that affected edema within the last 30 days prior to enrollment (e.g., diuretics, calcium channel blockers of the dihyropyridine class, pioglitazone, cox-1 inhibitors, pregabalin, and gabapentin, diltiazem, or fluctuating doses of systemic steroids).
- Use of systemic corticosteroids requiring daily administration at doses greater than 5mg of Prednisone per day or equivalent for greater than 2 weeks: low dose steroid administration (Prednisone up to 5 mg per day or equivalent) was allowable for an unlimited period of time. Topical steroid administration to peri-ulcer area or other skin was allowable but could not be applied to the ulcer itself.
- Currently pregnant or trying to become pregnant.
- Inability or unwillingness to participate in all aspects of study protocol.
- Exhibited any condition which, according to the Investigator, justified the subject's exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
- Currently participating in another clinical trial.
Additional Exclusion Criteria after two week run-in:
- Subject's target ulcer decreased in size by greater than 30% compared to the baseline area.
- Subject's target ulcer increased in size by greater than 50% compared to the baseline area.
- Subject's target ulcer measured less than 1.5cm² at the Randomization Visit.
- Subject appeared to have evidence of infection in any ulcer.
- The sum of the ulcer areas on the subject's study limb is > 50cm².
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual Action Pneumatic Compression Device
ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.
|
Dual action pneumatic compression device used to treat chronic VLUs.
Other Names:
|
Active Comparator: Multi-layer bandaging
PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.
|
Multi-layer bandaging used to treated chronic VLUs
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of VLU Area Reduction
Time Frame: Changes from Baseline to 16 weeks
|
Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
|
Changes from Baseline to 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-Reported Quality of Life
Time Frame: Changes from Baseline to 16 weeks
|
The Charing Cross Venous Ulcer Questionnaire assesses the patients' perception of their health when venous ulceration is present.
All items are scored so that a lower score defines a more favorable health state (a greater reduction is associated with improved quality of life).
In addition, each item is scored using a 1 to 5 range so that the lowest and highest possible scores are 0 and 100, respectively.
|
Changes from Baseline to 16 weeks
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Outpatient Costs
Time Frame: Changes from Baseline to 16 weeks
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Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
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Changes from Baseline to 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: William Marston, MD, University Of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
February 9, 2016
First Submitted That Met QC Criteria
February 11, 2016
First Posted (Estimate)
February 12, 2016
Study Record Updates
Last Update Posted (Actual)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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