search
Back to results

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

Primary Purpose

Venous Leg Ulcers, Diabetic Foot Ulcers

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PICO System
tNPWT System
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Venous Leg Ulcers focused on measuring Venous leg ulcer, ulcer, venous stasis, compression, diabetic foot ulcers, dfu, vlu

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • ILD Consulting, Inc.
  • Valley Foot & Ankle Specialty Providers
  • The Sun Healthcare & Surgery Group
  • Center for Clincial Research
  • Olive View - UCLA Medical Center
  • University of Miami
  • NW University Feinberg School of Medicine
  • Rosalind Franklin University of Med & Science
  • Ochsner Health System
  • Rubin Institute for Advanced Orthopedics
  • Advanced Foot & Ankle
  • Center for Advanced Wound Care
  • Acclaim Bone & Joint
  • Futuro Clinical Trials, LLC
  • Carilion Clinic
  • The Mayer Institute
  • Centre podiatrique et soins des plaies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PICO System

tNPWT System

Arm Description

Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 10, 2015
Last Updated
April 3, 2020
Sponsor
Smith & Nephew, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02470806
Brief Title
Single-Use Negative Pressure Wound Therapy System vs. Traditional Negative Pressure Wound Therapy System (tNPWT)
Acronym
NPWT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2015 (Actual)
Primary Completion Date
November 14, 2017 (Actual)
Study Completion Date
November 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Leg Ulcers, Diabetic Foot Ulcers
Keywords
Venous leg ulcer, ulcer, venous stasis, compression, diabetic foot ulcers, dfu, vlu

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PICO System
Arm Type
Experimental
Arm Description
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
Arm Title
tNPWT System
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PICO System
Intervention Description
Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
Intervention Type
Device
Intervention Name(s)
tNPWT System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Ulcer Area From Baseline to the End of the Treatment Period
Description
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.
Time Frame
Baseline through 12 weeks
Title
Percentage Change in Ulcer Area From Baseline to the End of the Treatment Period
Description
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.
Time Frame
Baseline through 12 weeks
Secondary Outcome Measure Information:
Title
Change in Target Ulcer Depth Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Description
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.
Time Frame
Baseline through 12 weeks
Title
Change in Target Ulcer Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Description
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.
Time Frame
Baseline through 12 weeks
Title
Percentage Change in Target Ulcer Depth and Volume Following Treatment With Either PICO or tNPWT From Baseline Over the 12-week Treatment Period
Description
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.
Time Frame
Baseline through 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Weymann, MD, MBA
Organizational Affiliation
Smith & Nephew, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
ILD Consulting, Inc.
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Valley Foot & Ankle Specialty Providers
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
The Sun Healthcare & Surgery Group
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
Center for Clincial Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Olive View - UCLA Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
NW University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rosalind Franklin University of Med & Science
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Ochsner Health System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Rubin Institute for Advanced Orthopedics
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Advanced Foot & Ankle
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Center for Advanced Wound Care
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Acclaim Bone & Joint
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Futuro Clinical Trials, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24013
Country
United States
Facility Name
The Mayer Institute
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8R 2R3
Country
Canada
Facility Name
Centre podiatrique et soins des plaies
City
Boucherville
State/Province
Quebec
ZIP/Postal Code
J4B 5E4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs