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

NCT02880592 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2020-02-19

No results posted yet for this 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.

Conditions

  • Diabetic Foot Ulcers

Interventions

OTHER

Affinity Allograft

fresh hypothermically stored human amniotic membrane

OTHER

Standard of care

offloading, debridement, infection management using appropriate dressings

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Katie Mowry, PhD · NuTech Medical, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-04-01
Completion
2019-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880592 on ClinicalTrials.gov