NCT01490879

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

A Randomized, Prospective, Double-blind, Vehicle-controlled, Dose-ranging, Multi-center Study to Assess the Safety and Clinical Effect of Nexagon® in the Treatment of Subjects With a Diabetic Foot Ulcer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: OcuNexus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2011-12-13
• Last updated: 2014-05-01

Locations

25 sites across 3 countries: United States, Russia, Ukraine