NCT02120755

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

First QC Date

April 21, 2014

Last Update Submit

March 1, 2016

Conditions

Diabetic Foot UlcersWound Care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

AmnioClear™

ACTIVE COMPARATOR

AmnioClear™ Human Allograft Amniotic Membrane

Biological: AmnioClear™ Human Allograft Amniotic Membrane

Standard of Care

NO INTERVENTION

Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing)

Interventions

AmnioClear™ Human Allograft Amniotic MembraneBIOLOGICAL
AmnioClear™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 23, 2014

Primary Completion

October 1, 2014

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(1)