N/A
N=132
SNaP Wound Care System Versus Traditional NPWT Device for Treatment of Chronic Wounds
Ulcers · Wounds
Bottom Line
View on ClinicalTrials.gov: NCT00951080 ↗Enrolled (actual)
132
Serious AEs
1.5%
Results posted
Oct 2020
Primary outcome: Primary: Percent Change in Wound Area — -85.7; -94 percentage of baseline wound area
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Traditional NPWT System (Device); SNaP Wound Care System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- 3M
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Wound Area |
-85.7; -94 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject has Venous Ulcer or Diabetic Ulcer with a surface area 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 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
Data sourced from ClinicalTrials.gov (NCT00951080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.