A Multicenter, Prospective, Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care Versus Matched Controls in the Management of Nonhealing Pressure Ulcers
Purpose
A multicenter, prospective, clinical trial evaluating a single-layer amniotic membrane (XPURT) and standard of care versus matched controls in the management of nonhealing pressure ulcers.
Conditions
- Pressure Ulcer
- Ulcer, Pressure
- Pressure Wound
- Pressure Area
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 through stage 4 without exposed 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 100 cm2 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. - There is undermining at the wound edge or tunnelling. - 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(For diabetics only). - 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). - 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 has participated in a clinical trial involving treatment with an investigational product within the previous 30 days. - 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 <17 as measured on the Mini Nutritional Assessment. - The potential subject has a known or suspected sensitivity to glutaraldehyde solutions.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- It is a prospective multicenter controlled clinical trial using matched controls.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard of Care |
Debridement, off-loading, reduction of bacterial burden, and proper moisture balance using dressings. |
|
|
Experimental XPURT + SOC |
Single-layer amniotic membrane plus standard of care. |
|
Recruiting Locations
Serena Group- Monroeville
Monroeville 5201734, Pennsylvania 6254927 15146
Monroeville 5201734, Pennsylvania 6254927 15146
More Details
- Status
- Recruiting
- Sponsor
- Applied Biologics, LLC
Detailed Description
This study is a multi-center, prospective, controlled clinical study consisting of 100 subjects from up to 30 providers. The subjects receive XPURT and SOC. The target ulcers are evaluated weekly by the investigator. The subject is treated once a week, to receive weekly applications of XPURT + SOC for 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 both arms, for the purpose of changing only (1) the secondary dressing in the XPURT arm or (2) change the standard of care dressing in the control arm.