CAMPR-II RWE TRIAL: A Saline-hydrated Allogeneic Dual-layer Amniotic Membrane Product or a Synthetic, Resorbable Polymeric Wound Matrix to a Coarsened Exact Matched Retrospective Control Cohort of Hard to Heal DFUs and VLUs

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

CAMPR-II Trial: A multicenter hybrid platform trial comparing the effects of a prospective cohort treated with a saline-hydrated allogeneic dual-layer amniotic membrane product or a synthetic, resorbable polymeric wound matrix to a coarsened exact matched retrospective control cohort of patients with hard-to-heal DFUs and VLUs

A vizsgálat 3 csoportja

• IP1: Membrane Wrap - HydroA vizsgált kezelés

  The study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)

  Kezelés: IP 1: Membrane Wrap - Hydro

• IP2: Microlyte®A vizsgált kezelés

  This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)

  Kezelés: Microlyte®

• Standard of CareNincs vizsgálati kezelés, összehasonlításként

  This study will employ a platform umbrella design in which two studies will be run: one for diabetic foot ulcers and one for venous leg ulcers. Each study will have two intervention groups and one common SOC group. Subjects will be randomized to one of two interventions: IP1: BioLab Membrane Wrap Lite IP2: BioLab Tri-Membrane Wrap Subjects in the control group will be drawn from deidentified data sourced from the US Wound Registry. The US Wound Registry (USWR) is recognized by CMS as a Qualified Clinical Data Registry (QCDR). The matching of intervention to control groups will use coarsened exact matching (CSM) in which key variables are used to match: e.g., age, sex, baseline wound area, baseline wound age. The desired control subject pool should be three times larger than the prospective group (at least 147 in wound type.)