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

Withdrawn before enrolling · Phase 4

Conditions studied: Diabetic Foot Ulcers, Wound Care

In brief

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.

Key facts

Study ID

NCT02120755

Run by

Liventa Bioscience

People needed

0

Last updated by the study team

2016-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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