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Slow enrollment
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The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honey Impregnated Dressing | Experimental | Honey Impregnated Dressing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey Impregnated Dressing | Device | The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Necrotic Tissue | The percent change in necrotic tissue will serve as the primary endpoint. | From initial date of application to weekly visits assessed up to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Closure | Percent of patients with 100% wound closure in each group | From initial date of application to weekly visits assessed up to 4 weeks. |
| Infections | Number of infections in the wound sites will be recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Illinois Foot & Ankle Specialists | Lake in the Hills | Illinois | 60156 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Honey Impregnated Dressing | Honey Impregnated Dressing Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Honey Impregnated Dressing | Honey Impregnated Dressing Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Necrotic Tissue | The percent change in necrotic tissue will serve as the primary endpoint. | Posted | Mean | 95% Confidence Interval | percent of necrotic tissue | From initial date of application to weekly visits assessed up to 4 weeks. |
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baseline to 4 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 | Honey Impregnated Dressing | Honey Impregnated Dressing Honey Impregnated Dressing: The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Martynenko | Medline Industries, Inc | 2242163822 | smartynenko@medline.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2018 | Aug 12, 2019 | Prot_SAP_000.pdf |
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| From initial date of application to weekly visits assessed up to 4 weeks. |
| Odor | The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor. | The odor score will be recorded at weekly visits over four weeks for each subject. |
| Pain Score | The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain. | The pain score will be recorded at weekly visits over four weeks for each subject. |
| Bates-Jensen Wound Assessment Tool Score | The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. The minimum total score is 9 and the maximum total score is 65. | The BWAT score will be recorded at weekly visits over fours weeks for each subject. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| 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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| Participants |
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| Secondary | Wound Closure | Percent of patients with 100% wound closure in each group | Posted | Count of Participants | Participants | From initial date of application to weekly visits assessed up to 4 weeks. |
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| Secondary | Infections | Number of infections in the wound sites will be recorded. | Posted | Count of Participants | Participants | From initial date of application to weekly visits assessed up to 4 weeks. |
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| Secondary | Odor | The odor score will be recorded using a scale of 1-4 with a score of 1 being pleasant odor to 4 being an unpleasant odor. | Study staff reported scores of 0 when no odor was detectable. | Posted | Median | Full Range | score on a scale | The odor score will be recorded at weekly visits over four weeks for each subject. |
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| Secondary | Pain Score | The pain score will be recorded with a visual analog scale from 0-10. 0 is interpreted as no pain and 10 is the worst imaginable pain. | Posted | Median | Full Range | score on a scale | The pain score will be recorded at weekly visits over four weeks for each subject. |
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| Secondary | Bates-Jensen Wound Assessment Tool Score | The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. The minimum total score is 9 and the maximum total score is 65. | Posted | Mean | 95% Confidence Interval | score on a scale | The BWAT score will be recorded at weekly visits over fours weeks for each subject. |
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| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| Abscess | Infections and infestations | Systematic Assessment |
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