Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs

Part of paid clinical trials in Circleville, Ohio.

Sponsor
Stability Biologics
Study ID
NCT06560502
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of Care-DFU — OTHER
    Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
  • AmnioCore - DFU — OTHER
    Participants will receive weekly applications of AmnioCore and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
  • Amnio Quad-Core - DFU — OTHER
    Participants will receive weekly applications of Amnio Quad-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
  • Standard of Care-VLU — OTHER
    Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and compression) until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
  • Amnio Tri-Core - VLU — OTHER
    Participants will receive weekly applications of Amnio Tri-Core and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
  • AmnioCore Pro — OTHER
    Participants will receive weekly applications of AmnioCore Pro and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.
  • Amniocore Pro + — OTHER
    Participants will receive weekly applications of Amniocore Pro + and Standard of Care until ulcer closure, or a maximum of 13 weeks, whichever occurs first.

Study Details

This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.

Key Dates

Start date
Aug 1, 2024
Status verified
Jan 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
324 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care-DFU
    Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Off-loading using the off-loading boot or total contact cast (TCC) provided by SerenaGroup.
  • Experimental: AmnioCore - DFU
    Dual layer, amniotic membrane allograft.
  • Experimental: Amnio Quad-Core - DFU
    Four layer, amniotic membrane allograft.
  • Experimental: Amniocore Pro + - DFU
    Dual layer, amnion/chorion membrane allograft.
  • Active Comparator: Standard of Care-VLU
    Debridement, reduction of bacterial burden, and proper moisture balance using dressings provided by SerenaGroup. Compression using multilayer compression wraps provided by SerenaGroup.
  • Experimental: Amnio Tri-Core - VLU
    Three layer, amniotic membrane allograft.
  • Experimental: AmnioCore Pro - VLU
    Three layer, amnion/chorion/amnion membrane allograft.

Primary Outcome Measure

Determine the between-arm difference [ Time Frame: 1-12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cutting Edge ResearchCirclevilleOhio43113
Brock Liden, MD
614-519-7845

Find similar trials in Circleville, OH

By research site
Cutting Edge Research· Circleville, OH

Related Studies