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

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00951080
• Collaborator: (none)
• Enrollment: 132
• Locations: 17
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 7.8
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcers; Wounds	Device: Traditional NPWT System; Device: SNaP Wound Care System	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lower Extremity Venous and Diabetic Ulcer Negative Pressure Wound Therapy Trial.
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SNaP Wound Care System	Device: SNaP Wound Care System; Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Active Comparator: Traditional NPWT System	Device: Traditional NPWT System; Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.

Outcome Measures

Primary Outcome Measures

1. Percent Change in Wound Area [Baseline and 16 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hope Research Institute	Phoenix	Arizona	United States	85050
2	Southern Arizona Limb Salvage Alliance (SALSA)	Tucson	Arizona	United States	85724
3	Center for Clinical Research, Inc.	Castro Valley	California	United States	94546
4	Jay Mukker, DPM Inc.	Fresno	California	United States	93726
5	Palomar Pomerado Health Wound Care Center	Poway	California	United States	92078
6	O'Connor Wound Care Clinic	San Jose	California	United States	95128
7	John Muir Wound Care Center	Walnut Creek	California	United States	94598
8	Georgetown University Hospital	Washington	District of Columbia	United States	20007
9	Bethesda Health City Wound Care Center	Boynton Beach	Florida	United States	33437
10	Wound Care on Wheels, LLC	Jacksonville	Florida	United States	32216
11	Osceola Regional Medical Center	Kissimmee	Florida	United States	34741
12	Weil Foot & Ankle Institute	Des Plaines	Illinois	United States	60016
13	LA Cardiovascular & Limb Salvage Center	Lafayette	Louisiana	United States	70506
14	University of North Carolina	Chapel Hill	North Carolina	United States	27599
15	The Christ Hospital, Wound Healing Center	Cincinnati	Ohio	United States	45219
16	New Bridge Medical Research Corporation	Warren	Pennsylvania	United States	16365
17	Southwest Washington Medical Center Wound Healing Center	Vancouver	Washington	United States	98664

Sponsors and Collaborators

• 3M

Investigators

• Principal Investigator: David G Armstrong, DPM, Ph.D., Southern Arizona Limb Salvage Alliance (SALSA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT00951080
• Other Study ID Numbers: SNP041609
• First Posted: Aug 4, 2009
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Keywords provided by 3M: ulcer; venous; diabetic; wounds and injuries
• Additional relevant MeSH terms: Ulcer; Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	SNaP Wound Care System	Traditional NPWT System
Arm/Group Description	SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.	Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
Period Title: Overall Study
STARTED	64	68
COMPLETED	38	41
NOT COMPLETED	26	27

Baseline Characteristics

Arm/Group Title	SNaP Wound Care System	Traditional NPWT System	Total
Arm/Group Description	SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.	Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.	Total of all reporting groups
Overall Participants	64	68	132
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.0 (14.2)	65.6 (15.6)	65.3 (14.9)
Sex: Female, Male (Count of Participants)
Female	33 51.6%	25 36.8%	58 43.9%
Male	31 48.4%	43 63.2%	74 56.1%
Race/Ethnicity, Customized (Count of Participants)
Ethnicity (White)	44 68.8%	43 63.2%	87 65.9%
Unknown	20 31.3%	25 36.8%	45 34.1%
Region of Enrollment (participants) [Number]
United States	64 100%	68 100%	132 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SNaP Wound Care System	Traditional NPWT System
Arm/Group Description	SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.	Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
Measure Participants	59	56
Median (Full Range) [percentage of baseline wound area]	-85.7	-94

Adverse Events

Arm/Group Title	SNaP Wound Care System		Traditional NPWT System
Arm/Group Description	SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.		Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
All Cause Mortality
	SNaP Wound Care System		Traditional NPWT System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		0/68 (0%)
Serious Adverse Events
	SNaP Wound Care System		Traditional NPWT System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/64 (0%)		2/68 (2.9%)
Infections and infestations
Infection of study wound (Venous Leg Ulcer)	0/64 (0%)		1/68 (1.5%)
Cellulitis right foot (Venous Leg Ulcer)	0/64 (0%)		1/68 (1.5%)
Other (Not Including Serious) Adverse Events
	SNaP Wound Care System		Traditional NPWT System
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/64 (21.9%)		18/68 (26.5%)
General disorders
Pain (wound)	1/64 (1.6%)		4/68 (5.9%)
Infections and infestations
Infection	2/64 (3.1%)		5/68 (7.4%)
Skin and subcutaneous tissue disorders
Maceration	10/64 (15.6%)		13/68 (19.1%)
Allergic reaction to dressing	4/64 (6.3%)		5/68 (7.4%)
Blisters	3/64 (4.7%)		4/68 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.