Ulcers, Wounds
Conditions
Keywords
ulcer, venous, diabetic, wounds and injuries
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.
Interventions
DEVICETraditional NPWT System
Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations.
DEVICESNaP Wound Care System
Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
Sponsors
3M
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SNaP Wound Care System SNaP Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. | 64 |
| Traditional NPWT System Traditional NPWT System: Standard wound dressing applications followed by negative pressure system application per manufacturer recommendations. | 68 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Other | 19 | 22 |
| Overall Study | Physician Decision | 4 | 1 |
Baseline characteristics
| Characteristic | SNaP Wound Care System | Traditional NPWT System | Total |
|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 14.2 | 65.6 years STANDARD_DEVIATION 15.6 | 65.3 years STANDARD_DEVIATION 14.9 |
| Race/Ethnicity, Customized Ethnicity (White) | 44 Participants | 43 Participants | 87 Participants |
| Race/Ethnicity, Customized Unknown | 20 Participants | 25 Participants | 45 Participants |
| Region of Enrollment United States | 64 participants | 68 participants | 132 participants |
| Sex: Female, Male Female | 33 Participants | 25 Participants | 58 Participants |
| Sex: Female, Male Male | 31 Participants | 43 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 68 |
| other Total, other adverse events | 14 / 64 | 18 / 68 |
| serious Total, serious adverse events | 0 / 64 | 2 / 68 |
Outcome results
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)
Time frame: Baseline and 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SNaP Wound Care System | Percent Change in Wound Area | -85.7 percentage of baseline wound area |
| Traditional NPWT System | Percent Change in Wound Area | -94 percentage of baseline wound area |