Evaluating 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
Purpose
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.
Conditions
- Pressure Ulcer
- Ulcer
- Ulcer, Pressure
- Pressure Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Prospective Modified Platform Multicenter Clinical Trial Utilizing Matched Controls.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ACApatch™ + SOC |
Human amniotic membrane tissue allografts derived from human placental tissue. |
|
|
Experimental caregraFT™ + SOC |
Human amniotic membrane tissue allografts derived from human placental tissue. |
|
|
Active Comparator Standard of Care |
Standard of care will be cleaning, debridement, and ulcer moisture balance. |
|
Recruiting Locations
Serena Group
Monroeville, Pennsylvania 15146
Monroeville, Pennsylvania 15146
More Details
- NCT ID
- NCT06999590
- Status
- Recruiting
- Sponsor
- Tiger Biosciences, LLC.
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.