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

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

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).

Key facts

Study ID

NCT03547635

Run by

Integra LifeSciences Corporation

People needed

116

Starts

2018-05-03

Expected to finish

2019-02-26

Last updated by the study team

2020-07-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• California 1 — Fresno, California, United States
• California 3 — Fresno, California, United States
• California 2 — Los Angeles, California, United States
• Georgia 1 — Gainesville, Georgia, United States
• Illinois 1 — Springfield, Illinois, United States
• New Jersey 1 — Toms River, New Jersey, United States
• Texas 1 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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