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

Phase 4

Withdrawn

• Conditions: Diabetic Foot Ulcers; Wound Care

• Registration Number: NCT02120755
• Lead Sponsor: Liventa Bioscience

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-23
• Primary Completion: 2014-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in Wound Size	12 Weeks	Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States