Not provided
Not provided
Not provided
Not provided
Not provided
Study was terminated due to a re-prioritization of ongoing studies.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrillar Collagen Powder Dressing | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrillar collagen powder dressing | Device | A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wound Size Over Twelve Week Period | Baseline to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bates-Jensen Wound Assessment Tool | The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Windy Cole | Cleveland Foot and Ankle Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Foot and Ankle Clinic | Cleveland | Ohio | 44103 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fibrillar Collagen Powder Dressing | Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study terminated prematurely due to re-prioritization of study efforts. Data not assessed.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fibrillar Collagen Powder Dressing | Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 Wound Size Over Twelve Week Period | Study terminated prematurely due to re-prioritization of study efforts. Data not assessed. | Posted | Baseline to 84 days |
|
|
Baseline to 12 weeks
Study terminated prematurely due to re-prioritization of study efforts. Serious Adverse Events were assessed and reported. Other non serious adverse events were not assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fibrillar Collagen Powder Dressing | Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Martynenko | Medline Industries, Inc | 2242163822 | smartynenko@medline.com |
Not provided
| 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 | Jan 21, 2019 | Aug 12, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline to 84 days |
| Change in Reported Pain Level | The pain score will be recorded with a verbal numeric pain rating scale from 0-10. | Baseline to 84 days |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race/Ethnicity, Customized |
| Region of Enrollment | participants |
|
|
| Secondary | Change in Bates-Jensen Wound Assessment Tool | The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. 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. | Study terminated prematurely due to re-prioritization of study efforts. Data not assessed. | Posted | Baseline to 84 days |
|
|
| Secondary | Change in Reported Pain Level | The pain score will be recorded with a verbal numeric pain rating scale from 0-10. | Study terminated prematurely due to re-prioritization of study efforts. Data not assessed. | Posted | Baseline to 84 days |
|
|
| 1 |
| 3 |
| 3 |
| 3 |
| 0 |
| 0 |
| Infection | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided