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NCT02120755 Clinical Trial

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

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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
See also
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Not yet recruiting NCT00916292 - Safety Study of Topical Human FGF-1 for Wound Healing Phase 1
Completed NCT01154374 - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot) Phase 2