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This study is being conducted to characterize the way leg wounds respond to a new type of wound dressing, compared to wounds in patients who are not using the new dressing. The investigators will collect wound fluid for biochemical analysis, and they will measure the wound healing that occurs with and without the new dressing.
Abnormal wound healing is characterized by prolonged inflammation and excess degradation of the extracellular matrix through the activity of proteinases and other enzymes. Wound fluids can provide biochemical information about the healing status of chronic wounds and the effects of wound treatments. In this study the investigators will obtain samples of wound fluid and measure healing in wounds randomized to receive the novel dressing or a control. The findings will be compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| novel dressing | Active Comparator | Treatment with novel dressing |
|
| Control | No Intervention | Control is treatment without novel dressing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel Dressing | Device | Topical wound dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Matrix Metalloproteinase Level in Wound Fluid | Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | change in wound area mean was calculated for each subject Mean and sd were calculated for each group | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ginger Salvadalena, PhD, RN | Hollister Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Heart Hospital | Phoenix | Arizona | 85006 | United States | ||
| Phoenix Baptist Hospital |
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4 subjects attended only one study visit thus did not have evaluable data
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| ID | Title | Description |
|---|---|---|
| FG000 | Novel Dressing | Treatment with novel dressing Novel Dressing: Topical wound dressing |
| FG001 | Control | Control is treatment without novel dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Novel Dressing | Treatment with novel dressing Novel Dressing: Topical wound dressing |
| BG001 | Control | Control is treatment without novel dressing |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Matrix Metalloproteinase Level in Wound Fluid | Wound fluid will be collected and analyzed at baseline and approximately every 7 days. Mean was calculated for each subject. Means and standard deviation were calculated for the treatment and control groups. | Overall mean across 8 week timeframe | Posted | Mean | Standard Deviation | mcg/ml | 8 weeks |
|
Up to 12 weeks
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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 | Novel Dressing | Treatment with novel dressing Novel Dressing: Topical wound dressing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Global Clinical Affairs | Hollister Incorporated | 8479183996 | ginger.salvadalena@hollister.com |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Phoenix |
| Arizona |
| 85015 |
| United States |
| University of Miami, Department of Surgery, Div. of Vascular Surgery | Miami | Florida | 33136 | United States |
| Alexian Brothers Medical Center Wound Healing Center | Elk Grove Village | Illinois | 60007 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| NYU Langone Medical Center | New York | New York | 10010 | United States |
| Circleville Foot & Ankle | Circleville | Ohio | 43113 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Wound Healing | change in wound area mean was calculated for each subject Mean and sd were calculated for each group | average across 12 week time frame | Posted | Mean | Standard Deviation | square cm | 12 weeks |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Control | Control is treatment without novel dressing | 0 | 16 | 0 | 16 |
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| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |