Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers

Part of paid clinical trials in Philidelphia, Pennsylvania.

Sponsor
BioLab Holdings
Study ID
NCT07089602
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 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 12 weeks, whichever occurs first.
  • Tri-Membrane Wrap™ DFU — OTHER
    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.
  • Membrane Wrap™ DFU — OTHER
    Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
  • Membrane Wrap-Lite™ DFU — OTHER
    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.
  • Membrane Wrap-Hydro™ DFU — OTHER
    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.
  • 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 12 weeks, whichever occurs first.
  • Tri-Membrane Wrap™ VLU — OTHER
    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.
  • Membrane Wrap™ VLU — OTHER
    Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
  • Membrane Wrap-Lite™ VLU — OTHER
    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.
  • Membrane Wrap-Hydro™ VLU — OTHER
    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.

Study Details

The purpose of this study is to evaluate the efficacy of human placental membrane products and standard of care versus standard of care alone in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Key Dates

Start date
Jul 15, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Active Comparator: DFU Standard of Care
    Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Off-loading using the off-loading boot or total contact cast (TCC).
  • Experimental: DFU Tri-Membrane Wrap™ + SOC
    Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
  • Experimental: DFU Membrane Wrap™ + SOC
    Membrane Wrap™ is an allograft derived from human amniotic membrane.
  • Experimental: DFU Membrane Wrap-Lite™ + SOC
    Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
  • Experimental: DFU Membrane Wrap-Hydro™ + SOC
    Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.
  • Active Comparator: VLU Standard of Care
    Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps.
  • Experimental: VLU Tri-Membrane Wrap™ + SOC
    Tri-Membrane Wrap™ is an allograft derived from human amniotic membrane.
  • Experimental: VLU Membrane Wrap™ + SOC
    Membrane Wrap™ is an allograft derived from human amniotic membrane.
  • Experimental: VLU Membrane Wrap-Lite™ + SOC
    Membrane Wrap-Lite™ is an allograft derived from human amniotic membrane.
  • Experimental: VLU Membrane Wrap-Hydro™ + SOC
    Membrane Wrap-Hydro™ is an allograft derived from human amniotic membrane.

Primary Outcome Measure

Determine the between-arm difference percentage of subjects achieving complete closure of target ulcer over 12 weeks. [ Time Frame: 1-12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Foot and Ankle DisordersPhilidelphiaPennsylvania19146
Ryan Breisinger
[email protected]
412-965-5737

Find similar trials in Philidelphia, PA

By research site
Center for Foot and Ankle Disorders· Philidelphia, PA

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