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.
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Pennsylvania
Center for Foot and Ankle Disorders
RECRUITING
Philidelphia
Contact Information
Primary
Bennett Sarver
info@serenagroups.com
1-833-865-6300
Backup
Thomas Serena, MD
Info@serenagroups.com
1-833-865-6300
Time Frame
Start Date:2026-01-02
Estimated Completion Date:2027-01
Participants
Target number of participants:50
Treatments
Other: Tri-Membrane Wrap™ DFU
Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap™ DFU
Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Lite™ DFU
Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Hydro™ DFU
Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
Other: Tri-Membrane Wrap™ VLU
Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap™ VLU
Membrane Wrap™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Lite™ VLU
Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
Other: Membrane Wrap-Hydro™ VLU
Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.