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

Phase 4WithdrawnNCT02120755

Liventa Bioscience

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Diabetic Foot Ulcers Wound Care

Interventions

AmnioClear™ Human Allograft Amniotic MembraneBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke University

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Reduction in Wound Size

Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time.

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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