Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs

Part of paid clinical trials in Metairie, Louisiana.

Sponsor
C5 Biomedical
Study ID
NCT06674980
Status
Recruiting
Apply to this trial

Conditions

  • Cardiovascular Diseases
  • Diabetes Complications
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Diabetic Angiopathies
  • Diabetic Foot
  • Diabetic Neuropathies
  • Endocrine System Disease
  • Foot Diseases
  • Foot Ulcer
  • Foot Ulcer Unhealed
  • Glucose Metabolism Disorders
  • Leg Ulcer
  • Metabolic Diseases
  • Pathologic Processes
  • Skin Diseases
  • Skin Ulcer
  • Ulcer
  • Vascular Diseases

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.
  • AM/Single - DFU — OTHER
    Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
  • AM/Double - DFU — OTHER
    Participants will receive weekly applications of AM/Double 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.
  • AM/Single - VLU — OTHER
    Participants will receive weekly applications of AM/Single and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
  • AM/Double - VLU — OTHER
    Participants will receive weekly applications of AM/Double and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Study Details

The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.

Key Dates

Start date
Dec 20, 2024
Status verified
Dec 2024
Primary completion
Nov 22, 2026
Completion
Jan 22, 2027

Study Design

Enrollment
177 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. Off-loading using the off-loading boot or total contact cast (TCC).
  • Experimental: AM/Single - DFU
    AM/Single is an air-dried, sterile single layer human amniotic membrane allograft.
  • Experimental: AM/Double - DFU
    AM/Double is an air-dried, sterile double layer human amniotic membrane allograft.
  • Active Comparator: Standard of Care - VLU
    Debridement, reduction of bacterial burden, and proper moisture balance using dressings. Compression using multilayer compression wraps.
  • Experimental: AM/Single - VLU
    AM/Single is an air-dried, sterile single layer human amniotic membrane allograft.
  • Experimental: AM/Double - VLU
    AM/Double is an air-dried, sterile double layer human amniotic membrane allograft.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Poirot PodiatryMetairieLouisiana70001
Donna Belette
[email protected]
504-919-3668

Find similar trials in Metairie, LA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Poirot Podiatry· Metairie, LA

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