Last updated on September 2018

Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers

Brief description of study

This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.

Detailed Study Description

This study is a multi-center, randomized, controlled open-label study designed to evaluate the safety and effectiveness of Affinity fresh amniotic membrane plus standard of care therapy (SOC) versus SOC in the treatment of diabetic foot ulcers.

The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management. A number of offloading systems are commercially available. The choice of offloading will be at the discretion of the Principal Investigator but should be total contact casting, fixed ankle walker boot, or equivalent device to the fixed ankle walker boot.

The study will have two phases: Screening and Treatment.

The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility. At the first Screening Phase Visit, the Investigator will select the study (target) ulcer. Each subject will have only one DFU selected as the study (target) ulcer. In the situation in which a subject has more than one DFU at the S1 visit, the Investigator will select the largest DFU that meets the eligibility criteria of the protocol as the study (target) ulcer. Subjects whose target ulcer has been treated with SOC for 2 weeks are eligible to enter the treatment phase immediately once all of the inclusion and exclusion criteria are met. If the ulcer has not received SOC, the subject should be placed into SOC and enrolled in the study after 14 days of offloading.

The Treatment Phase (12 weeks) begins with a series of assessments designed to confirm the subjects' continued eligibility. Investigators will debride the ulcer, if required. Subjects whose ulcers continue to meet eligibility criteria will then be randomized to 1 of 2 groups: (1) standard of care plus weekly application of fHSAM for up to 4 weeks and thereafter per treatment guidelines (2) standard of care. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photos. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subject will be seen weekly ( 3 days) until the ulcer is healed or study exit if the study ulcer area has not been reduced by at least 40% within 6 weeks, or 1 week after last application treatment week 12.

Clinical Study Identifier: NCT02880592

Contact Investigators or Research Sites near you

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Giselle Ojeda, DPM

GF Professional Research
Miami Lakes, FL United States
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Robert Snyder, DPM

Barry University Clinical Research
North Miami Beach, FL United States
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David Guthrie, MD

Summit Health Hospital
Chambersburg, PA United States
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Matthew Sabo, DPM

The Foot and Ankle Wellness Center
Ford City, PA United States
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Keyur Patel, DO

Armstrong County Memorial Hospital
Kittanning, PA United States
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Bryan Doner, DO

SerenaGroup Research Institute
Pittsburgh, PA United States
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Maria Kasper, DPM

Martin Foot and Ankle
York, PA United States
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Brian Loder, DPM

Henry Ford Macomb Hospital
Clinton Township, MI United States
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