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.

Part of paid clinical trials in Philidelphia, Pennsylvania.

Sponsor
BioLab Holdings
Study ID
NCT07364630
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • 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.
  • 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 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.

Key Dates

Start date
Jan 2, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

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

Arms

  • 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.

Primary Outcome Measure

Percentage of Wound Closure [ 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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