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

Diabetic Foot Ulcers Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01490879
Study type Interventional
Source CoDa Therapeutics Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2012
Completion date April 2014
View Details
See also
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Completed NCT00013299 - Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3 Phase 2
Completed NCT00013286 - A Prospective Study of Endothelial Dysfunction and Diabetic Foot Ulcer Risk Phase 2
Terminated NCT02667327 - A Study of Granexin Gel in the Treatment of Diabetic Foot Ulcer Phase 3
Not yet recruiting NCT00916292 - Safety Study of Topical Human FGF-1 for Wound Healing Phase 1
Completed NCT01154374 - A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot) Phase 2