Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment.
Subjects will be recruited from those presenting to the wound clinic and meet the inclusion criteria. A total of 30 evaluable subjects will be recruited for this study from up to 2 wound care clinics /home health agencies (15 in Home Care and 15 in Extended Care). Subjects will be followed by weekly wound assessments for a period of 12 weeks or until their wounds heal. The outcome measurement is the rate of healing over the 12 week period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| P400 support surface | Experimental | All patients will receive the P400 mattress |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P400 mattress | Device | The P400 mattress will be placed for a period of 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ulcer Surface Area at Week 12 | The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of New Ulcers | incidence of new ulcers while on the study surface | 12 Weeks |
| Healing Rate Per Week | The mean change in area per week for all ulcers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Randall Wolcott, MD | Randall Wolcott and Assoiciates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Regional Wound Care Center | Lubbock | Texas | 79410 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | P400 | All patients will receive the P400 mattress P400 mattress: The P400 mattress will be placed for a period of 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients with multiple Stage II or at least one Stage III or IV pressure ulcer having less than or equal to 25% necrotic tissue present in the pressure ulcer at the time of placement.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | P400 | All patients will receive the P400 mattress P400 mattress: The P400 mattress will be placed for a period of 12 weeks. |
| 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 | Change From Baseline in Ulcer Surface Area at Week 12 | The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer. | Ulcers decreased an average of 7.96 cm^2 (+/- 8.1 cm^2) over the 12 week period | Posted | Mean | Standard Deviation | cm^2 | 12 Weeks | All Pressure Ulcers | Participants |
|
|
Not provided
Not provided
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 | P400 Support Surface | All patients will receive the P400 mattress for a period of 12 weeks |
Not provided
Not provided
Small study with no comparative arm.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randy Wolcott | Wolcott and Associates | 806-793-8869 | lisa@randallwolcott.com |
Not provided
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| All Pressure Ulcers |
|
|
| Secondary | Incidence of New Ulcers | incidence of new ulcers while on the study surface | Posted | Number | percentage of participants | 12 Weeks |
|
|
|
| Secondary | Healing Rate Per Week | The mean change in area per week for all ulcers | Rate of change in area (healing) for all ulcers on all subjects in area (cm^2)/week | Posted | Mean | Standard Deviation | cm^2/week | 12 weeks | all ulcers | Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
Not provided
Not provided