VLU Non-Inferiority Study Comparing a Dual Action Pneumatic Compression Device to Multi-Layer Bandaging

NCT ID: NCT02680834

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dual Action Pneumatic Compression Device

ACTitouch dual action pneumatic compression system used daily during wakeful hours for up to 16 weeks.

Group Type: EXPERIMENTAL

Dual Action Pneumatic Compression Device

Intervention Type: DEVICE

Dual action pneumatic compression device used to treat chronic VLUs.

Multi-layer bandaging

PROFORE or Coban 2 to be worn 24 hours daily for up to 16 weeks.

Group Type: ACTIVE_COMPARATOR

Multi-Layer Bandaging

Intervention Type: DEVICE

Multi-layer bandaging used to treated chronic VLUs

Interventions

Dual Action Pneumatic Compression Device

Dual action pneumatic compression device used to treat chronic VLUs.

Intervention Type: DEVICE

Multi-Layer Bandaging

Multi-layer bandaging used to treated chronic VLUs

Intervention Type: DEVICE

Other Intervention Names

ACTitouch system; Profore or Coban 2

Eligibility Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tactile Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Marston, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Phoenix VA Health Care System

Phoenix, Arizona, United States

Associated Foot and Ankle Specialists, LLC

Phoenix, Arizona, United States

Arizona Regional Medical Research

Tucson, Arizona, United States

ILD Research Center

Carlsbad, California, United States

Limb Preservation Platform - Northwest

Fresno, California, United States

Limb Preservation Platform - Downtown

Fresno, California, United States

Long Beach VA Healthcare System

Long Beach, California, United States

UCLA Medical Center

Los Angeles, California, United States

Greater Los Angeles VA Healthcare System

Los Angeles, California, United States

VA San Diego Healthcare System

San Diego, California, United States

Olive View - UCLA Medical Center

Sylmar, California, United States

University of Miami

Miami, Florida, United States

Barry University Clinical Research

North Miami Beach, Florida, United States

Foot and Ankle Institute of South Florida

South Miami, Florida, United States

Boston Medical Center

Boston, Massachusetts, United States

Stony Brook University

Stony Brook, New York, United States

UNC School of Medicine

Chapel Hill, North Carolina, United States

Jobst Vascular Institute

Toledo, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32451241 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

6010

Identifier Type: -

Identifier Source: org_study_id