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SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds

Primary Purpose

Ulcers, Wounds

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional NPWT System
SNaP Wound Care System
Sponsored by
3M
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcers focused on measuring ulcer, venous, diabetic, wounds and injuries

Eligibility Criteria

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

Inclusion Criteria:

  • Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm
  • Subject has wound present for >30 days despite appropriate wound care
  • Subject has adequate blood perfusion (Defined as either transcutaneous oxygen measurements of the dorsum of the foot >30 mmHg or 0.7 < ABI <1.2)
  • Subject has wound in location amendable to creation of airtight seal around wound using NPWT dressings
  • Subject is able to understand and provide written consent
  • Subject able to understand and provide written consent
  • Male or non-pregnant female willing to have urine pregnancy test

Exclusion Criteria:

  • Subject has Active Infection (Redness, Swelling, Pain, Purulent Exudate)
  • Subject has Untreated Osteomyelitis
  • Subject has Allergy to Wound Care Products used in the study
  • Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound
  • Subject has Active Charcot Arthropathy of the Foot
  • Subject has study wound location on toes or plantar surface of foot
  • Subject has uncontrolled hyperglycemia (HbA1C >12%)
  • Subject has end stage renal disease requiring dialysis
  • Subject is undergoing active chemotherapy treatment that inhibits wound healing
  • Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrollment
  • Subject has a >30% wound surface area reduction in size at 1 week after screening visit
  • Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study
  • Subject is unwilling or unable to comply with protocol requirements
  • Subject is pregnant

Sites / Locations

  • Hope Research Institute
  • Southern Arizona Limb Salvage Alliance (SALSA)
  • Center for Clinical Research, Inc.
  • Jay Mukker, DPM Inc.
  • Palomar Pomerado Health Wound Care Center
  • O'Connor Wound Care Clinic
  • John Muir Wound Care Center
  • Georgetown University Hospital
  • Bethesda Health City Wound Care Center
  • Wound Care on Wheels, LLC
  • Osceola Regional Medical Center
  • Weil Foot & Ankle Institute
  • LA Cardiovascular & Limb Salvage Center
  • University of North Carolina
  • The Christ Hospital, Wound Healing Center
  • New Bridge Medical Research Corporation
  • Southwest Washington Medical Center Wound Healing Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SNaP Wound Care System

Traditional NPWT System

Arm Description

Outcomes

Primary Outcome Measures

Percent Change in Wound Area
The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)

Secondary Outcome Measures

Full Information

First Posted
July 31, 2009
Last Updated
July 29, 2022
Sponsor
3M
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1. Study Identification

Unique Protocol Identification Number
NCT00951080
Brief Title
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
Official Title
Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate a novel negative pressure wound therapy (NPWT) device called the SNaP device compared to a traditional NPWT device for the treatment of lower extremity diabetic and venous ulcer wounds.
Detailed Description
This is a prospective, randomized, two-arm, non-inferiority, multi-center study comparing negative pressure therapy wound healing outcomes between the SNaP Wound Care System and traditional NPWT systems.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers, Wounds
Keywords
ulcer, venous, diabetic, wounds and injuries

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SNaP Wound Care System
Arm Type
Experimental
Arm Title
Traditional NPWT System
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Traditional NPWT System
Intervention Description
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
Intervention Type
Device
Intervention Name(s)
SNaP Wound Care System
Intervention Description
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Primary Outcome Measure Information:
Title
Percent Change in Wound Area
Description
The percent change in wound area as measured from Visitrak tracings (Value at 16 weeks minus value at baseline / value at baseline)
Time Frame
Baseline and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has Venous Ulcer or Diabetic Ulcer with a surface area < 100 sq. cm and < 10 cm in widest diameter on lower extremity, but larger than 1 sq. cm Subject has wound present for >30 days despite appropriate wound care Subject has adequate blood perfusion (Defined as either transcutaneous oxygen measurements of the dorsum of the foot >30 mmHg or 0.7 < ABI <1.2) Subject has wound in location amendable to creation of airtight seal around wound using NPWT dressings Subject is able to understand and provide written consent Subject able to understand and provide written consent Male or non-pregnant female willing to have urine pregnancy test Exclusion Criteria: Subject has Active Infection (Redness, Swelling, Pain, Purulent Exudate) Subject has Untreated Osteomyelitis Subject has Allergy to Wound Care Products used in the study Subject has Malignancy, Burn, Collagen Vascular Disease, Sickle Cell, Vasculopathy, or Pyoderma Gangrenosum Origin of Wound Subject has Active Charcot Arthropathy of the Foot Subject has study wound location on toes or plantar surface of foot Subject has uncontrolled hyperglycemia (HbA1C >12%) Subject has end stage renal disease requiring dialysis Subject is undergoing active chemotherapy treatment that inhibits wound healing Subject has had previous treatment with NPWT device, growth factors, hyperbaric oxygen, or bioengineered tissue product within 30 days of enrollment Subject has a >30% wound surface area reduction in size at 1 week after screening visit Subject has any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study Subject is unwilling or unable to comply with protocol requirements Subject is pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Armstrong, DPM, Ph.D.
Organizational Affiliation
Southern Arizona Limb Salvage Alliance (SALSA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Southern Arizona Limb Salvage Alliance (SALSA)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Center for Clinical Research, Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Jay Mukker, DPM Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
Palomar Pomerado Health Wound Care Center
City
Poway
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
O'Connor Wound Care Clinic
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
John Muir Wound Care Center
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Bethesda Health City Wound Care Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33437
Country
United States
Facility Name
Wound Care on Wheels, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Osceola Regional Medical Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Weil Foot & Ankle Institute
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
LA Cardiovascular & Limb Salvage Center
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
The Christ Hospital, Wound Healing Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
New Bridge Medical Research Corporation
City
Warren
State/Province
Pennsylvania
ZIP/Postal Code
16365
Country
United States
Facility Name
Southwest Washington Medical Center Wound Healing Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21362084
Citation
Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. Wound Repair Regen. 2011 Mar-Apr;19(2):173-80. doi: 10.1111/j.1524-475X.2010.00658.x.
Results Reference
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SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds

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