A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

Liventa Biosciences

Status and phase: Withdrawn; Phase 4

Conditions: Wound Care; Diabetic Foot Ulcers

Treatments: Biological: AmnioClear™ Human Allograft Amniotic Membrane

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120755

Amn-DFU-01

Details and patient eligibility

About

This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.

The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Stable Type I or II diabetes mellitus
• At least one chronic diabetic ulcer
• Full-thickness ulcer size from 1-8 cm2.

Exclusion criteria

• Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
• Bleeding disorders
• Ulcer with muscle, tendon, capsule or bone involvement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

AmnioClear™

Active Comparator group

Description:

AmnioClear™ Human Allograft Amniotic Membrane

Treatment:

Biological: AmnioClear™ Human Allograft Amniotic Membrane

Standard of Care

No Intervention group

Description:

Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing)