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NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers

NCT02461641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2019-02-22

No results posted yet for this study

Summary

This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.

Conditions

  • Foot Ulcer, Diabetic

Interventions

OTHER

NuShield

NuShield is a sterilized dehydrated amnion chorion membrane patch.

OTHER

Affinity

Affinity is a aseptically produced hypothermically stored amniotic membrane patch.

OTHER

Standard of Care

Standard of Care for this study is defined as sharp debridement, moist wound dressing and offloading of the area using a DARCO shoe.

Sponsors & Collaborators

  • Organogenesis

    collaborator INDUSTRY

  • NuTech Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Katie Mowry, PhD · NuTech Medical, a division of Organogenesis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-04-30
Completion
2018-10-25

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 NCT02461641 on ClinicalTrials.gov