Diabetic Foot Ulcer Clinical Trial
Official title:
Evaluating Clinical Acceptance of a NPWT Wound Care System to Expected Standards of Care in Post-acute Patients With a Variety of Wound Types
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.
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
;
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