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

NCT02680834 | Terminated Results DMC

• 1 other identifier: 6010
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 18

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.

Conditions

Venous Leg Ulcer

Keywords

venous stasis ulcer; wound; chronic venous insufficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  Changes from Baseline to 16 weeks

Secondary Outcomes (2)

• Patient-Reported Quality of Life

  Changes from Baseline to 16 weeks

• Outpatient Costs

  Changes from Baseline to 16 weeks

Study Arms (2)

Dual Action Pneumatic Compression Device

EXPERIMENTAL

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

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.

Device: Multi-Layer Bandaging

Interventions

Dual Action Pneumatic Compression Device DEVICE

Dual action pneumatic compression device used to treat chronic VLUs.

Also known as: ACTitouch system

Dual Action Pneumatic Compression Device

Multi-Layer Bandaging DEVICE

Multi-layer bandaging used to treated chronic VLUs

Also known as: Profore or Coban 2

Multi-layer bandaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tactile Medical: lead

Study Sites (18)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

Associated Foot and Ankle Specialists, LLC

Phoenix, Arizona, 85015, United States

Location

Arizona Regional Medical Research

Tucson, Arizona, 85710, United States

Location

ILD Research Center

Carlsbad, California, 92009, United States

Location

Limb Preservation Platform - Northwest

Fresno, California, 93720, United States

Location

Limb Preservation Platform - Downtown

Fresno, California, 93721, United States

Location

Long Beach VA Healthcare System

Long Beach, California, 90822, United States

Location

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

Greater Los Angeles VA Healthcare System

Los Angeles, California, 90073, United States

Location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33169, United States

Location

Foot and Ankle Institute of South Florida

South Miami, Florida, 33143, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

UNC School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

Related Publications (1)

• 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.

  PMID: 32451241 DERIVED

MeSH Terms

Conditions

Varicose Ulcer; Wounds and Injuries

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination led to small numbers of subjects analyzed. Study was terminated early so the device could undergo a complete re-design to address physician feedback collected during the trial.

Results Point of Contact

• Title: Clinical Research Director
• Organization: TactileMedical

astone@tactilemedical.com

612-540-5267

Study Officials

• William Marston, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 12, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 19, 2020
• Results First Posted: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)