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The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VAC GranuFoam Bridge Dressing | Experimental | This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V.A.C. Negative Pressure Wound Therapy System | Device | This is a non-invasive wound treatment system that uses controlled, localized negative pressure to create an environment that promotes wound healing in chronic and acute wounds |
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Use Assessment | Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes. | 48-72 hours (+6 hours) time period |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North American Center for Limb Preservation | New Haven | Connecticut | 06515 | United States | ||
| Drs Research Network |
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| ID | Title | Description |
|---|---|---|
| FG000 | V.A.C Bridge Dressing | This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| South Miami |
| Florida |
| 33143 |
| United States |
| Key Stone Medical Research Associates | Bethlehem | Pennsylvania | 18018 | United States |
| Alamo Clinical Research Consultants | San Antonio | Texas | 78212 | United States |
| Alamo Family Foot and Ankle Care | San Antonio | Texas | 78258 | United States |
| Scott and White Dept of Surgery | Temple | Texas | 76508 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | V.A.C Bridge Dressing | This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ease of Use Assessment | Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes. | ITT (Intent to Treat) population. | Posted | Count of Participants | Participants | 48-72 hours (+6 hours) time period |
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1 week
Adverse Events were assessed at each protocol scheduled visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VAC GranuFoam Bridge Dressing | This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours. | 0 | 33 | 0 | 33 | 8 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Maceration | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Global Clinical Affairs | KCI | 2102555595 | jane.hart@kci1.com |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| 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 |
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| Hispanic or Latino |
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| American Indian or Alaskan Native |
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| 4-Excellent |
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| Ease of Comfortability |
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| Ease of Dressing Removal |
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