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COMPLETED Phase 2

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

NCT01490879 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Nexagon® Low Dose
  • DRUG Nexagon® Medium Dose
  • DRUG Nexagon® High Dose
  • DRUG Nexagon® vehicle

Study Locations (20)

Other

  • Kemerovo Regional Clinical Hospital — Kemerovo
  • City Clinical Hospital #13 — Moscow
  • Endocrinology Science Center — Moscow
  • Endocrinology Clinic of Moscow, Department of Healthcare — Moscow
  • Moscow Medical University n.a. — Moscow
  • Federal bureau of medical and social expertise, Moscow — Moscow
  • St Petersburg City Hospital of St Elizabeth — Saint Petersburg
  • St Petersburg Diagnostic Center — Saint Petersburg
  • Voronezh Regional Clinical Consultative Diagnostic Center — Voronezh
  • Cherkasy Regional Clinical Hospital, Endocrinology Department — Cherkasy
  • Dnipropetrovsk Regional Clinical Hospitaln. a. I.I. Mechnikov — Dnipropetrovsk

Florida

  • Barry University Clinical Research — Hialeah
  • Univeristy of Miami, Miller School of Medicine, Dermatology Research — Miami
  • Doctors Research Network — South Miami

Arizona

  • Associated Foot and Ankle Specialists, LLC — Phoenix
  • University of Arizona Medical Center — Tucson

California

  • Center For Clinical Research Inc. — Castro Valley
  • Advanced Foot Care and Clinical Research Center — Fresno

Nevada

  • Advanced Foot and Ankle Center — Las Vegas

Texas

  • Houston Foot and Ankle Care — Houston

Trial Details

FieldValue
Enrollment Target 168 participants
Start Date 2012-07
Est. Completion 2014-04
Phase Phase 2

Sponsor

OcuNexus Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01490879

The ClinicalTrials.gov registry entry for NCT01490879 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OcuNexus Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Diabetic Foot Ulcers appearing as the primary indexed condition, and to 4 interventions — of which Nexagon® Low Dose is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01490879 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Other, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01490879 about?

NCT01490879 is a clinical study titled "A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)". 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 stand...

What is the current status of trial NCT01490879?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2012-07. Estimated completion is 2014-04.

What conditions does trial NCT01490879 study?

This clinical trial studies the following conditions: Diabetic Foot Ulcers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01490879?

The interventions under investigation include: Nexagon® Low Dose (DRUG), Nexagon® Medium Dose (DRUG), Nexagon® High Dose (DRUG), Nexagon® vehicle (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01490879?

This trial is sponsored by OcuNexus Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01490879 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Nevada, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial