Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT) (NPWT)

A Prospective, Randomized, Comparative Effectiveness Study of a Single-Use, Negative Pressure Wound Therapy System (PICO) Versus a Traditional Negative Pressure Wound Therapy System (tNPWT) in the Treatment of Lower Extremity Ulcers

The aim of this study is to compare the clinical efficacy of two types of NPWT systems; the traditional negative pressure wound therapy (tNPWT) system and the single-use negative pressure wound therapy (PICO) system.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcers; Venous Leg Ulcers
• Intervention / Treatment: Device: PICO System; Device: tNPWT System

Detailed Description

The two types of NPWT systems include the tNPWT system that has successfully completed a coding verification request with CMS and has the following capabilities (e.g., range of negative pressure, connective tubing, canister, foam or gauze filler, and approved for home use), and a portable, canister-less, battery operated, disposable PICO system to see if there are any observed differences with regard to the clinical efficacy of the two devices.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8R 2R3
      • The Mayer Institute
  • Quebec
    • Boucherville, Quebec, Canada, J4B 5E4
      • Centre Podiatrique et Soins des Plaies
• United States
  • California
    • Carlsbad, California, United States, 92009
      • ILD Consulting, Inc.
    • Fresno, California, United States, 93720
      • Valley Foot & Ankle Specialty Providers
    • Martinez, California, United States, 94553
      • The Sun Healthcare & Surgery Group
    • San Francisco, California, United States, 94115
      • Center for Clincial Research
    • Sylmar, California, United States, 91342
      • Olive View - UCLA Medical Center
  • Florida
    • Miami, Florida, United States, 33125
      • University of Miami
  • Illinois
    • Chicago, Illinois, United States, 60611
      • NW University Feinberg School of Medicine
    • North Chicago, Illinois, United States, 60064
      • Rosalind Franklin University of Med & Science
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health System
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Rubin Institute for Advanced Orthopedics
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Advanced Foot & Ankle
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Center for Advanced Wound Care
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Acclaim Bone & Joint
    • McAllen, Texas, United States, 78501
      • Futuro Clinical Trials, LLC
  • Virginia
    • Roanoke, Virginia, United States, 24013
      • Carilion Clinic

Participation Criteria

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:

• Provide informed consent
• Age ≥ 18 years and of either sex
• Willing to comply with protocol instructions, including allowing all study assessments
• Have a Venous Leg Ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 36.0 cm2
• Target ulcer duration ≥ 4 weeks but ≤ 104 weeks (24 months)
• Have a Diabetic Foot Ulcer (DFU) present on any part of the plantar or dorsum surface of the foot, with a surface area ≥ 0.5 cm2 and ≤ 10.0 cm2
• Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone
• Target ulcer duration ≥ 4 weeks but ≤ 52 weeks (12 months)
• Acceptable state of health and nutrition

EXCLUSION CRITERIA

• Therapy with another investigational agent within thirty (30) days of Screening, or during the study Ulcers which are deemed as highly exuding, per the Investigator's discretion.
• Current diagnosis of osteomyelitis at the target wound location that is not currently receiving treatment [Documented history of resolved osteomyelitis is allowed].
• Subjects with a VLU: Refusal of or inability to tolerate compression therapy.
• Clinical evidence of target ulcer infection
• Current systemic therapy with cytotoxic drugs.
• Current therapy with chronic (> 10 days) oral corticosteroids.
• Previous treatment with NPWT device or hyperbaric oxygen within 7 days of screening.
• Malignancy in the target ulcer, or history of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PICO System; Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface	Device: PICO System; Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
Active Comparator: tNPWT System; Traditional NPWT (tNPWT) from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.	Device: tNPWT System; NPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ulcer Area From Baseline to the End of the Treatment Period	Ulcer area was photographed in order to determine the measurements of the post-debridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.	Baseline through 12 weeks
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period	Ulcer area was photographed in order to determine the measurements of the postdebridement ulcer area (cm^2 and total percentage [%]) using the ARANZ Silhouette wound imaging and measurement device.	Baseline through 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period	Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.	Baseline through 12 weeks
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period	Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.	Baseline through 12 weeks
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period	Ulcer area was analyzed for depth measurement in millimeters (mm), volume measurement in cubic centimeters (cm^3), and percentage change (%) including terms for treatment, baseline depth, baseline volume, wound type, pooled sites, and wound duration using the ARANZ Silhouette wound imaging and measurement device.	Baseline through 12 weeks

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Study Chair: Andy Weymann, MD, MBA, Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2015
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): November 14, 2017

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 12, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: compression; ulcer; Venous leg ulcer; venous stasis; diabetic foot ulcers; dfu; vlu
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: CE-052PIC