AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

Not Applicable

Completed

Interventions: Device: A Marketed Comparator
Other: Standard of Care
Other: AMNIOEXCEL Plus Amniotic Membrane

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).

Recruitment & Eligibility

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 cm2.
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.
In the opinion of the Investigator, the subject has a condition that could inhibit wound healing.
The subject has ulcers secondary to a disease other than diabetes.

Arm && Interventions

Group	Intervention	Description
A Marketed Comparator	A Marketed Comparator	-
Standard of Care	Standard of Care	-
AMNIOEXCEL Plus Amniotic Membrane	AMNIOEXCEL Plus Amniotic Membrane	-

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (7): Georgia 1
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Gainesville, Georgia, United States
Illinois 1
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Springfield, Illinois, United States
New Jersey 1
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Toms River, New Jersey, United States
California 1
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Fresno, California, United States
California 3
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Fresno, California, United States
California 2
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Los Angeles, California, United States
Texas 1
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San Antonio, Texas, United States