A Prospective, Multi-Center, Randomized, Parallel-group Study Comparing AMNIOEXCEL Plus Placental Allograft Membrane to a Marketed Comparator and Standard of Care Procedures in the Management of Diabetic Foot Ulcers

Integra LifeSciences Corporation7 sites in 1 country116 target enrollmentMay 3, 2018

ConditionsDiabetic Foot Ulcer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot Ulcer
Sponsor: Integra LifeSciences Corporation
Enrollment: 116
Locations: 7
Primary Endpoint: The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).

Registry

clinicaltrials.gov

Start Date

May 3, 2018

End Date

February 26, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Integra LifeSciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have participated in the informed consent process and signed a study-specific informed consent document.
•Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device.
•Be ≥ 21 years of age.
•Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12%.
•Have at least one diabetic foot ulcer Ulcer size (i.e., area) is \> 1 cm2 and \< 12 cm
•Have adequate vascular perfusion of the affected limb

Exclusion Criteria

•The subject was previously randomized and treated under this clinical study protocol.
•The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone.
•The subject is unable to safely ambulate with the use of a study required offloading boot.
•The subject has suspected or confirmed gangrene or wound infection of the study ulcer.
•The subject has suspected or confirmed osteomyelitis.
•In the opinion of the Investigator, the subject has received or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of wound healing
•The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy prior to signing the Informed Consent Form for trial participation.
•The subject is currently pregnant or is actively trying to conceive.
•In the opinion of the Investigator, the subject is unable to comply with the treatment regimen
•In the opinion of the Investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with wound healing.

Outcomes

Primary Outcomes

The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.

Time Frame: Wound closure assessed up to week 12 and confirmed 2 weeks later; only participants with wound closure at or before Week 12 and who maintained closure in follow-up reported

Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.