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| Name | Class |
|---|---|
| Joseph M. Still Research Foundation, Inc. | OTHER |
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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):
**Study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented**
B. Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invia Motion Endure | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invia Motion Endure | Device | NPWT Invia Motion Endure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine if Invia Motion Endure supports acceptable progress towards the goal of therapy for DFU and PI/PU wounds | Goal of the therapy will be defined by the physician according to initial assessment:
**Study endpoint will be determined by physician at the time of enrolment, when the goal of therapy is documented** | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of ease of use and satisfaction | A weekly survey will be obtained from the wound clinic staff members to determine ease of use and satisfaction | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adequate management of the exudate | Measurament of exudate (ml, number of canisters used) will be performed | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
Patient not willing to comply with f/u clinic visits.
Subjects with
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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert F Mullins, MD | Joseph M. Still Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Still Research Foundation | Augusta | Georgia | 30909 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19903300 | Background | Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human skin wounds: a major and snowballing threat to public health and the economy. Wound Repair Regen. 2009 Nov-Dec;17(6):763-71. doi: 10.1111/j.1524-475X.2009.00543.x. | |
| Background | Morrison Informatics, Inc. A comprehensive cost analysis of medicare home oxygen therapy: A study for the American Association for Homecare. June 27, 2006. | ||
| Background | C. Marquardt et. al. "Negative pressure wound therapy using PHMB gauze for the management of postoperative subcutaneous surgical site infections" Coloproctology" 36:364-369, 2014 |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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non-randomized
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| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |