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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02120755

Enrollment

Registered

2014-04-23

Start date

Unknown

Completion date

Unknown

Last updated

2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcers, Wound Care

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.

Interventions

BIOLOGICALAmnioClear™ Human Allograft Amniotic Membrane

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026