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| Name | Class |
|---|---|
| ExtremityCare, LLC. | UNKNOWN |
| SerenaGroup, Inc. | NETWORK |
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The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design. The initial plan is to evaluate two CAMPs; however, the modified platform design permits the inclusion of additional CAMPs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACApatch™ + SOC | Experimental | Human amniotic membrane tissue allografts derived from human placental tissue. |
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| caregraFT™ + SOC | Experimental | Human amniotic membrane tissue allografts derived from human placental tissue. |
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| Standard of Care | Active Comparator | Standard of care will be cleaning, debridement, and ulcer moisture balance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACApatch™ | Other | Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete closure | To determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing pressure ulcers with multiple CAMPs plus SOC versus matched SOC controls (mSOC) over 20 weeks using a modified platform trial design. | 1-20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Closure | To determine the between-arm difference in the time to closure over 16 weeks for CAMP plus SOC versus mSOC. | 1-20 weeks |
| Percentage Area Reduction | To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arshdeep Kaur, MS | Contact | 1-888-665-5005 | arshdeepk@tigerbios.com | |
| Khristina Harrel | Contact | 1-412-212-0123 | kharrell@serenagroups.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Serena, MD | Serena Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Serena Group | Recruiting | Monroeville | Pennsylvania | 15146 | United States |
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Prospective Modified Platform Multicenter Clinical Trial Utilizing Matched Controls.
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| caregraFT™ | Other | Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first. |
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| Standard of Care | Other | Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance) until ulcer closure, or a maximum of 20 weeks, whichever occurs first. |
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| 1-20 weeks |
| Determine Quality of Life | To determine the between-arm difference in pain for patients that present with a VAS score of greater than 4. Pain will be rated on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the most pain. | 1-20 weeks |
| Adverse Events | To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC. | 1-20 weeks |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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