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Affinity Prospective Diabetic Foot Trial Crossover Group

NCT03205436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-19

No results posted yet for this study

Summary

This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain criteria are met.

Conditions

  • Diabetic Foot Ulcer

Interventions

OTHER

Affinity human amniotic membrane

fresh hypothermically stored human amniotic membrane

Sponsors & Collaborators

  • SerenaGroup, Inc.

    collaborator NETWORK

  • Organogenesis

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2019-06-15
Completion
2019-08-15

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 NCT03205436 on ClinicalTrials.gov