MedTrace Logo

A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)

NCT01490879 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2014-05-01

No results posted yet for this study

Summary

This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care. Standard of care will include debridement of the ulcer, standardized dressings and standardized off-loading using a Removable Cast Walker.

Conditions

  • Diabetic Foot Ulcers

Interventions

DRUG

Nexagon® Low Dose

Twice weekly, topical application of Nexagon® low dose in addition to a Removable Cast Walker

DRUG

Nexagon® Medium Dose

Twice weekly, topical application of Nexagon® medium dose in addition to a Removable Cast Walker

DRUG

Nexagon® High Dose

Twice weekly, topical application of Nexagon® high dose in addition to a Removable Cast Walker

DRUG

Nexagon® vehicle

Twice weekly, topical application of Nexagon® vehicle in addition to a Removable Cast Walker

Sponsors & Collaborators

  • OcuNexus Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David G Armstrong, DPM MD PhD · S.A.L.S.A. , University of Arizona, Tucson, AZ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • United States
  • Russia
  • Ukraine

Study Locations

More Related Trials

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 NCT01490879 on ClinicalTrials.gov