DFU, Diabetic Foot Ulcer, Foot Ulcer Chronic, Leg Ulcers, Ulcer, Ulcer Foot, Venous Leg Ulcer, Venous Leg Ulcer (VLU), Venous Ulcer
Conditions
Keywords
Leg Ulcer, Ulcer, Venous Ulcer, Venous Leg ulcer, VLU, DFU, Diabetic Foot Ulcer, Foot Ulcer, Diabetic foot
Brief summary
The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.
Detailed description
This study follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products. Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).
Interventions
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERMembrane Wrap™ DFU
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHERMembrane Wrap™ VLU
Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
Sponsors
BioLab Holdings
Serena Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products. Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The potential subject must be at least 18 years of age or older. * The potential subject must have a diagnosis of type 1 or 2 Diabetes mellitus. * If the potential subject has two or more ulcers, the target ulcer must be the same ulcer treated in the BIOCAMP study. * The potential subject must consent to using the prescribed offloading method for the duration of the study. * 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 participated in the BIOCAMP trial in the SOC only arm and NOT achieved complete closure by the 12-week endpoint.
Exclusion criteria
* The potential subject is known to have a life expectancy of \< 6 months. * The potential subject's target ulcer is not secondary to diabetes. * The target ulcer is infected or there is cellulitis in the surrounding skin. * The target ulcer exposes tendon or bone. * There is evidence of osteomyelitis complicating the target ulcer. * There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy. * 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 is taking hydroxyurea. * The potential subject has applied topical steroids to the ulcer surface within one month of TV-1. * The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer. * The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of TV-1. * The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer. * 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 has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment. * The potential subject did not participate in the BIOCAMP trial. * The potential subject participated in the BIOCAMP trial and was not randomized to the SOC only arm. * The potential subject participated in the BIOCAMP trial and achieved complete closure. * The target ulcer was treated with CAMPs, also defined as skin substitute, or hyperbaric oxygen therapy (HBOT) in the month prior to TV-1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Wound Closure | 1-12 Weeks | The percentage of target ulcers achieving complete wound closure in 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Closure | 1-12 weeks | Time to closure for the target ulcer. |
| Percentage Area Reduction | 1-12 weeks | Percentage wound area reduction from TV-1 to TV-13 measured weekly with digital photographic planimetry, using imaging device, and physical examination. |
| Adverse Events | 1-12 Weeks | The number of product- or procedure- related adverse events. |
| Determine improvement in Quality of Life | 1-12 weeks | To determine the between-arm difference in the quality of life for subjects receiving HPM plus SOC compared to SOC alone using the Forgotten Wound Score (FWS) questionnaire. Forgotten wound scores situations on a scale of "never" to "mostly." |
| Pain in patients who present with VAS greater than 4 | 1-12 Weeks | To determine the between-arm difference in pain for patients that present with a Visual Analog Sale (VAS) score of greater than 4. The VAS has a scale of 0-10. 0 Meaning no pain and 10 being the worst pain |
Countries
United States
Contacts
CONTACTBennett Sarver
CONTACTThomas Serena, MD
Outcome results
None listed