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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNaP Wound Care System | Experimental |
| |
| Traditional NPWT System | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional NPWT System | Device | Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David G Armstrong, DPM, Ph.D. | Southern Arizona Limb Salvage Alliance (SALSA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85050 | United States | ||
| Southern Arizona Limb Salvage Alliance (SALSA) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21362084 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SNaP Wound Care System | SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. |
| FG001 | Traditional NPWT System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| SNaP Wound Care System | Device | Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. |
|
| Tucson |
| Arizona |
| 85724 |
| United States |
| Center for Clinical Research, Inc. | Castro Valley | California | 94546 | United States |
| Jay Mukker, DPM Inc. | Fresno | California | 93726 | United States |
| Palomar Pomerado Health Wound Care Center | Poway | California | 92078 | United States |
| O'Connor Wound Care Clinic | San Jose | California | 95128 | United States |
| John Muir Wound Care Center | Walnut Creek | California | 94598 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Bethesda Health City Wound Care Center | Boynton Beach | Florida | 33437 | United States |
| Wound Care on Wheels, LLC | Jacksonville | Florida | 32216 | United States |
| Osceola Regional Medical Center | Kissimmee | Florida | 34741 | United States |
| Weil Foot & Ankle Institute | Des Plaines | Illinois | 60016 | United States |
| LA Cardiovascular & Limb Salvage Center | Lafayette | Louisiana | 70506 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| The Christ Hospital, Wound Healing Center | Cincinnati | Ohio | 45219 | United States |
| New Bridge Medical Research Corporation | Warren | Pennsylvania | 16365 | United States |
| Southwest Washington Medical Center Wound Healing Center | Vancouver | Washington | 98664 | United States |
Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SNaP Wound Care System | SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. |
| BG001 | Traditional NPWT System | Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Median | Full Range | percentage of baseline wound area | Baseline and 16 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SNaP Wound Care System | SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. | 0 | 64 | 0 | 64 | 14 | 64 |
| EG001 | Traditional NPWT System | Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations. | 0 | 68 | 2 | 68 | 18 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection of study wound (Venous Leg Ulcer) | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis right foot (Venous Leg Ulcer) | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Maceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Allergic reaction to dressing | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain (wound) | General disorders | Systematic Assessment |
| ||
| Blisters | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Global Clinical Development | KCI | 12102555595 | jkhart@mmm.com |
| ID | Term |
|---|---|
| D014456 | Ulcer |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Unknown |
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