Study Title: A Multicenter, Prospective, Modified Platform Trial 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
A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.
Conditions
- Skin Ulcer
- Pressure Ulcer (PU)
- Pressure Ulcer of Skin
- Pressure Sore
- Chronic Ulcer
- Pressure Wound
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- The potential subject must be at least 18 years of age or older. - The potential subject must agree to attend the weekly study visits required by the protocol. - The potential subject must be willing and able to participate in the informed consent process. - 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). - At enrollment, the potential subject must have a target ulcer with a minimum surface area of 2 cm2 and a maximum surface area of 100cm2 measured post-debridement with the imaging device. - 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. - The potential subject's target ulcer is not a pressure ulcer. - The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin. - The target ulcer exposes tendon or bone. - The target ulcer has undermining or tunneling. - There is evidence of osteomyelitis complicating the target ulcer. - 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). - The potential subject has applied topical steroids to the ulcer surface within one month of initial screening. - The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit. - 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 × width is acceptable). - 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. - The potential subject is a woman who is pregnant or considering becoming pregnant within the next 6 months. - The potential subject has end stage renal disease requiring dialysis. - The potential subject, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments. - 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. - The potential subject has a malnutrition indicator score of <17 as measured on the Mini Nutritional Assessment. - Known hemoglobin of < 8 g/dL as this is an indicator of poor wound healing.
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 Activate™ Matrix + SOC |
Three layers: amnion, intermediate layer, and chorion |
|
|
Experimental AmnioDefend™ FT Matrix + SOC |
Three layers: amnion, intermediate layer, and chorion |
|
|
Experimental Palisade™ DM Matrix + SOC |
Two layers: amnion and chorion |
|
|
Experimental Sentry™ SL Matrix + SOC |
One layer: amnion |
|
|
Experimental Shelter™ DM Matrix + SOC |
Two layers: amnion and chorion |
|
Recruiting Locations
Amber Stormer
North Royalton, Ohio 44133
North Royalton, Ohio 44133
More Details
- Status
- Recruiting
- Sponsor
- Sequence LifeScience, Inc.
Detailed Description
This study is a multi-center, prospective, modified platform trial consisting of 2,000 subjects from up to Up to 75 providers at up to 25 investigational sites. The subjects are randomized to receive 1 of 5 treatments, either with Activate™ Matrix (CAMP-1) and SOC; AmnioDefend™ FT Matrix (CAMP-2) and SOC; Palisade™ Matrix (CAMP-3) and SOC; Sentry™ SL Matrix (CAMP-4) and SOC; Shelter™ DM Matrix (CAMP-5) and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of one of the five CAMPs + SOC or matched controls until or up to 20 weeks or until the study ulcer has completely closed (i.e. 100% closure as assessed by the investigator and confirmed 2 weeks later at the closure confirmation visit (CCV). One additional visit per week is optional, for the purpose of changing only the secondary dressing