Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

Status Completed

Clinical Trial Summary

This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the effectiveness of EPIFLO in combination with standard wound therapy on wound healing as compared to standard wound therapy alone; and 2) Screening for potential safety issues.

Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive debridement. Subjects will be randomized to either the Treatment arm or the Control arm. Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment Period, once two weeks after wound closure and once at the end of 12-week durability Period.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01291160
Study type	Interventional
Source	Ogenix Corporation
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	October 2009
Completion date	February 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02652754` - Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers	Phase 1
Completed	`NCT01070433` - A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers	Phase 2
Completed	`NCT00971048` - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds	N/A
Terminated	`NCT00762138` - The AutoloGel™ Post-Market Surveillance (TAPS) Program	N/A
Completed	`NCT00578604` - Non-Invasive Assessment of Wound Healing With Optical Methods	N/A
Completed	`NCT05417425` - Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers	Phase 1
Completed	`NCT02631512` - Evaluation of Woulgan in Diabetic Foot Ulcer	Phase 4
Completed	`NCT02222376` - Effect of Topic Pirfenidone in Diabetic Ulcers	Phase 3
Terminated	`NCT01816633` - Effectiveness of AutoloGel Therapy in Diabetic Foot Ulcers	N/A
Completed	`NCT01454401` - LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers	N/A
Completed	`NCT01221207` - Instant Total Contact Cast to Heal Diabetic Foot Ulcers	N/A
Withdrawn	`NCT01105884` - Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers	N/A
Completed	`NCT00536744` - Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers	Phase 3
Terminated	`NCT00316537` - Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers	Phase 1/Phase 2
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
Not yet recruiting	`NCT02672280` - Safety and Exploratory Efficacy Study of Collagen Membrane With Mesenchymal Stem Cells in the Treatment of Skin Defects	Phase 1/Phase 2