Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer
Conditions
Brief summary
Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
Detailed description
The primary objective of this study is to determine acceptable progress towards the goal of therapy for a diabetic foot ulcers (DFU) and pressure Injuries/ulcers (PI/PU) wounds when using the Medela Invia Motion Endure NPWT system during 4-week study duration. Goal of therapy will be defined by the physician according to initial assessment: Endpoints (dependent on goal of therapy): * Decrease in wound volume * Decrease in size of the tunneling area * Decrease in size of undermining * Decrease in amount of slough * Increase in granulation tissue * The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft. \*\*Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\*\* B. Secondary Objectives * To evaluate the ease of use from clinicians. * To evaluate overall satisfaction from clinicians. C. Tertiary Objectives * Adequate management of the exudate
Interventions
DEVICEInvia Motion Endure
NPWT Invia Motion Endure
Sponsors
Joseph M. Still Research Foundation, Inc.
Medela AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
non-randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects ≥18 years of age. * Signed, informed consent by patient or LAR within 72 hours of admission to burn center. * Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries/pressure ulcer. * Patient is comfortable (e.g. not in pain) * Patient is willing and able to adhere to treatment protocol.
Exclusion criteria
* Patient not willing to comply with f/u clinic visits. * Subjects with * Necrotic tissue with eschar present * Untreated osteomyelitis * Non-enteric and unexplored fistulas * Malignancy in wound * Exposed vasculature * Exposed nerves * Exposed anastomotic site of blood vessels or bypasses * Exposed organs * Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. * Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds | 4 weeks | Goal of the therapy will be defined by the physician according to initial assessment: * Decrease in wound volume * Decrease in size of the tunneling area * Decrease in size of undermining * Decrease in amount of slough * Increase in granulation tissue * The wound bed is progressing acceptably towards a transition to another treatment modality such as Moist Wound Healing (MWH), surgical closure, or a flap or graft. \*\*Study endpoint will be determined by physician at the time of enrolment, when the goal of therapy is documented\*\* |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of ease of use and satisfaction | 4 weeks | A weekly survey will be obtained from the wound clinic staff members to determine ease of use and satisfaction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adequate management of the exudate | 4 weeks | Measurament of exudate (ml, number of canisters used) will be performed |
Countries
United States
Outcome results
None listed