Venous Leg UlcerNCT02680834
VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging
A study testing Dual Action Pneumatic Compression Device and Multi-Layer Bandaging in people with Venous Leg Ulcer, run by Tactile Medical at 18 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Leg Ulcer
- What is being tested?
- Dual Action Pneumatic Compression Device and Multi-Layer Bandaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Boston Medical Center
Boston, Massachusetts, 02118
ILD Research Center
Carlsbad, California, 92009
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Limb Preservation Platform - Northwest
Fresno, California, 93720
Limb Preservation Platform - Downtown
Fresno, California, 93721
Long Beach VA Healthcare System
Long Beach, California, 90822
UCLA Medical Center
Los Angeles, California, 90024
Greater Los Angeles VA Healthcare System
Los Angeles, California, 90073
University of Miami
Miami, Florida, 33136
Barry University Clinical Research
North Miami Beach, Florida, 33169
Phoenix VA Health Care System
Phoenix, Arizona, 85012
Associated Foot and Ankle Specialists, LLC
Phoenix, Arizona, 85015
VA San Diego Healthcare System
San Diego, California, 92161
Foot and Ankle Institute of South Florida
South Miami, Florida, 33143
Stony Brook University
Stony Brook, New York, 11794
Olive View - UCLA Medical Center
Sylmar, California, 91342
Jobst Vascular Institute
Toledo, Ohio, 43606
Arizona Regional Medical Research
Tucson, Arizona, 85710
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Leg Ulcer
- Being tested
- Dual Action Pneumatic Compression Device, Multi-Layer Bandaging
- Keywords
- venous stasis ulcer, wound, chronic venous insufficiency
- Medical subject headings
- Varicose Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Action Pneumatic Compression DeviceDevice
Also called ACTitouch system
Dual action pneumatic compression device used to treat chronic VLUs.
Multi-Layer BandagingDevice
Also called Profore or Coban 2
Multi-layer bandaging used to treated chronic VLUs
| Study group | Role | What they receive |
|---|---|---|
| Dual Action Pneumatic Compression Device | Experimental | ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks. Receives: Device: Dual Action Pneumatic Compression Device |
| Multi-layer bandaging | Active comparator | PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks. Receives: Device: Multi-Layer Bandaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of VLU Area Reduction
Percentage of ulcer area reduction in the target VLU during the 16 week treatment period calculated by wound imaging software.
Measured: Changes from Baseline to 16 weeks
Secondary outcomes (2)
Patient-Reported Quality of Life
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.
Measured: Changes from Baseline to 16 weeks
Outpatient Costs
Assessment of the effect of the Actitouch compared to a standard regimen of multi-layer bandaging on mean total outpatient costs per subject.
Measured: Changes from Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017
- Study completionJun 2017
Why it stopped: The ACT was re-designed per physician feedback and patient compliance \& not because of safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Leg 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
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Marston, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680834
- Sponsor's protocol ID
- 6010
- Status last verified
- Jan 2020
- First submitted
- 9 Feb 2016
- Last updated
- 19 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Marston WA, Kirsner RS, Tallis A, Hanft JR, Walters J, Farber A; ACTitouch Investigators. Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial. J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):1031-1040.e1. doi: 10.1016/j.jvsv.2020.03.004. Epub 2020 May 22.
PubMed 32451241
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing a Dual Action Pneumatic Compression System Against Multi-Layer Bandaging Systems: A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT02680834
- Acronym / sponsor ID
- 6010
- Conditions
- Venous Leg Ulcer
- Keywords
- venous stasis ulcer, wound, chronic venous insufficiency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The ACT was re-designed per physician feedback and patient compliance \& not because of safety.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- Feb 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Posted 30 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual Action Pneumatic Compression Device | Experimental | Device: Dual Action Pneumatic Compression DeviceACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks. |
| Multi-layer bandaging | Active comparator | Device: Multi-Layer BandagingPROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| Dual Action Pneumatic Compression DeviceAlso: ACTitouch systemDual action pneumatic compression device used to treat chronic VLUs. | Device | Dual Action Pneumatic Compression Device |
| Multi-Layer BandagingAlso: Profore or Coban 2Multi-layer bandaging used to treated chronic VLUs | Device | Multi-layer bandaging |
Primary outcome
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.
2 secondary outcomes
Patient-Reported Quality of Life
Time frame: Changes from Baseline to 16 weeks
Outpatient Costs
Time frame: Changes from Baseline to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32451241Marston WA, Kirsner RS, Tallis A, Hanft JR, Walters J, Farber A; ACTitouch Investigators. Economic benefit of a novel dual-mode ambulatory compression device for treatment of chronic venous leg ulcers in a randomized clinical trial. J Vasc Surg Venous Lymphat Disord. 2020 Nov;8(6):1031-1040.e1. doi: 10.1016/j.jvsv.2020.03.004. Epub 2020 May 22.
- Individual participant dataSharing planned: No
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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.
William Marston, MD principal investigator
University of North Carolina, Chapel Hill
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Action Pneumatic Compression Device and Multi-Layer Bandaging in people with Venous Leg Ulcer, run by Tactile Medical at 18 sites in United States.
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 9 inclusion and 24 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: stopped early, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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?
Yes. Results are posted in the registry (first posted 30 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of VLU Area Reduction (time frame: Changes from Baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680834, which also lists 1 linked publication.
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 19 Feb 2020.