Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcers

In brief

The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers

Key facts

Study ID

NCT02209051

Run by

Integra LifeSciences Corporation

People needed

29

Starts

2014-07-01

Expected to finish

2015-08-01

Last updated by the study team

2017-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• an ambulatory person at least 18 years of age at the time of informed consent.
• type 1 or type 2 diabetes mellitus.
• glycosylated hemoglobin (HbA1c) of ≤12%
• at least one wound that is/has:
• Wagner grade 1 or superficial 2 (without bone, tendon or joint exposure),
• duration of at least 1 month,
• no clinical signs of infection or osteomyelitis,
• between 1cm2 and 25cm2 in area,
• per original protocol, closed <20% in area during the Screening Period; per Amendment #1, closed <30% in area during Screening and
• located on the foot, distal to malleoli.
• adequate circulation to the affected extremity
• serum creatinine of <3.0mg/dl.

You may not qualify if…

• participated in another clinical trial within 30 days prior to consent,
• Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
• receiving radiation or chemotherapy of any kind,
• known or suspected malignancy of current ulcer,
• pregnant or breast feeding,
• an active malignant disease,
• receiving hemo- or peritoneal dialysis,
• sickle cell anemia or Raynaud's syndrome,
• diagnosis of autoimmune connective tissue disease,
• received a biologic agent, growth factor, xenograft or skin equivalent in the 30 days prior to consent,
• exposed bone, tendon or joint capsule in the study ulcer,
• currently receiving antibiotics (for any reason), or
• taking medications considered to be immune system modulators.

Where it is running

• Associated Foot and Ankle Specialists, LLC — Phoenix, Arizona, United States
• Center for Clinical Research, Inc. — Castro Valley, California, United States
• Pacific Wound Center — Stockton, California, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Barry University Clinical Research — North Miami Beach, Florida, United States
• Beth Israel Deaconess Hospital - Plymouth — Plymouth, Massachusetts, United States
• Duke University — Durham, North Carolina, United States
• Wayne Memorial Hospital — Goldsboro, North Carolina, United States

Full record on ClinicalTrials.gov

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