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

Diabetic Foot Ulcers Clinical Trial

Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

• NCT number: NCT02880592
• Study type: Interventional
• Source: Organogenesis
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Completion date: April 1, 2019