Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
890
Trial Sponsor
Clinical Trial Start Date
2016
0Primary Completion Date
April 1, 2019
0Study Completion Date
April 1, 2019
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Other0
Intervention Name
Affinity Allograft0
Standard of care0
Interventional Trial Phase
Not Applicable0
Participating Facility
Official Name
A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers0
Last Updated
February 19, 2020
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0
Study 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.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
