Pressure Injury, Pressure Ulcer, Ulcer, Ulcer, Pressure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERACApatch™
Participants will receive weekly applications of ACApatch™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
OTHERcaregraFT™
Participants will receive weekly applications of caregraFT™ and Standard of Care until ulcer closure, or a maximum of 20 weeks, whichever occurs first.
OTHERStandard of Care
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.
Sponsors
ExtremityCare, LLC.
SerenaGroup, Inc.
Tiger Biosciences, LLC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective Modified Platform Multicenter Clinical Trial Utilizing Matched Controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The potential subject must be at least 18 years of age or older. 2. The potential subject must agree to attend the weekly study visits required by the protocol. 3. The potential subject must be willing and able to participate in the informed consent process. 4. The potential subject must have a full-thickness pressure ulcer NPIAP stage 3 or stage 4 without exposed tendon or bone of greater than or equal to one month in duration located on the trunk (sacral, trochanteric, or ischial). 5. At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100 cm2 measured post-debridement with the imaging device. 6. The potential subject has adequate off-loading of the ulcer.
Exclusion criteria
1. The potential subject is known to have a life expectancy of \< 3 months. 2. The potential subject's target ulcer is not a pressure ulcer. 3. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin. 4. The target ulcer exposes tendon or bone. 5. The target ulcer has undermining or tunneling. 6. There is evidence of osteomyelitis complicating the target ulcer. 7. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics). 8. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. 9. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. 10. The surface area of the potential subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (historical run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable). 11. The surface area measurement of the potential subject's target ulcer decreases by 25% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC. 12. The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months. 13. The potential subject has end stage renal disease requiring dialysis. 14. The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. 15. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit. 16. The potential subject has a malnutrition indicator score of \<17 as measured on the Mini Nutritional Assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete closure | 1-20 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Closure | 1-20 weeks | To determine the between-arm difference in the time to closure over 16 weeks for CAMP plus SOC versus mSOC. |
| Percentage Area Reduction | 1-20 weeks | To determine the between-arm difference in the percent area reduction (PAR) at weekly intervals the CAMP plus SOC arms versus mSOC. |
| Determine Quality of Life | 1-20 weeks | 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. |
| Adverse Events | 1-20 weeks | To evaluate the between-arm difference in the frequency and nature of adverse events in subjects receiving CAMP plus SOC versus mSOC. |
Countries
United States
Contacts
Primary ContactArshdeep Kaur, MS
Backup ContactKhristina Harrel
Outcome results
None listed