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NCT01490879 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Diabetic Foot Ulcers, sponsored by OcuNexus Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 20
- Study locations
NCT01490879: Completed Phase 2 study of Diabetic Foot Ulcers, sponsored by OcuNexus Therapeutics.
NCT01490879 is a Phase 2 study of Diabetic Foot Ulcers that has completed, run by OcuNexus Therapeutics. The registered enrollment target is 168 participants, below the 221-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01490879, a Phase 2 study of Diabetic Foot Ulcers, has completed, sponsored by OcuNexus Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT01490879 record still lists
NCT01490879 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 12 other Diabetic Foot Ulcers trials with a reported enrollment target (24% lower).
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.
NCT01490879 names 20 study sites across 6 states, led by Other, Florida, Arizona.
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.
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).
Who is sponsoring clinical trial NCT01490879?
This trial is sponsored by OcuNexus Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diabetic Foot Ulcers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01490879's enrollment target sits among peer trials
168 6th of 12 higher than 7 of 12 other Diabetic Foot Ulcers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot Ulcers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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