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Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers

NCT03855514 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-05-26

No results posted yet for this study

Summary

This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy.

Conditions

  • Diabetic Foot Ulcer

Interventions

OTHER

NuShield

NuShield® is a dehydrated placental allograft.

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Christine McLennan · Organogenesis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-08
Primary Completion
2021-11-30
Completion
2021-12-30

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 NCT03855514 on ClinicalTrials.gov