Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers

Conditions

• Chronic Foot Ulcers
• Diabetic Foot Ulcer (DFU)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Allograft — OTHER
  Placental-based Allografts

Study Details

The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.

Key Dates

Start date

Nov 14, 2024

Status verified

Feb 2025

Primary completion

Nov 18, 2026

Completion

Nov 18, 2026

Study Design

Enrollment

240 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: "Amnion/Chorion/Amnion" common/general allograft configuration
  Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a tri-layer dehydrated amniotic membrane allograft for the treatment of DFUs. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage.
• No Intervention: Standard of Care
  Standard of Care (SOC) for open chronic diabetic foot ulcer using a calcium alginate dressing and will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent) applied. Offloading of the DFU (removable offloading boot or total contact casting \[TCC\] if the subject's foot is too large for a removable offloading boot), appropriate sharp or surgical debridement, and infection management. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed.
• Other: "Amnion/Chorion" common/general allograft configuration
  Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dehydrated human amniotic membrane allograft comprised of a tri-layer membrane (amnion/intermediate layer/chorion) which provides a natural scaffold that allows cellular attachment and infiltration. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed.
• Other: "Amnion/Amnion" common/general allograft configuration
  Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dual layer dehydrated human amniotic membrane allograft. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage. This allograft provides a protective cover and supports the body's wound healing process. This allograft is supplied sterile and not intended to be removed.

Primary Outcome Measure

Percentage of DFUs healed at 12 weeks [ Time Frame: 12 Weeks ]

Central Contacts

• Frank Burrows III, MBA, EMT, BCMAS, CWCA
  888-494-4441
  [email protected]
• Mora Melican, PH.D.
  888-494-4441
  [email protected]

Locations (9)

Find similar trials in Fresno, CA

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