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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02120755
Other study ID # Amn-DFU-01
Secondary ID
Status Withdrawn
Phase Phase 4
First received April 21, 2014
Last updated March 1, 2016

Study information

Verified date March 2016
Source Liventa Bioscience
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
AmnioClear™ Human Allograft Amniotic Membrane


Locations

Country Name City State
United States Duke University Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Liventa Bioscience

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in Wound Size Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time. 12 Weeks No
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