Evaluation of Topical Wound Oxygen (two2) Therapy

Diabetic Ulcer Clinical Trial

Official title:
A Randomized, Double-blinded, Parallel Group, Placebo-Controlled, Multi-Center Trial of Topical Wound Oxygen Therapy in the Treatment of Diabetic Lower Extremity Ulcers

Status Terminated

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of the Topical Wound Oxygen (two2) therapy system on the healing of diabetic lower extremity ulcers.

Clinical Trial Description

The AOTI two2 therapy trial is a randomized, double-blinded, parallel group, placebo-controlled, multi-center study intended to evaluate the efficacy of Topical Wound Oxygen (two2) therapy in relation to placebo when added to standard of care in the treatment of diabetic lower extremity ulcers. ;

Study Design

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

Related Conditions & MeSH terms

Diabetic Ulcer

Clinical Trial Details

NCT number	NCT00871312
Study type	Interventional
Source	AOTI Ltd.
Contact
Status	Terminated
Phase	N/A
Start date	May 2007
Completion date	December 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00804414` - Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers	Phase 3
Completed	`NCT00638872` - Polydeoxyribonucleotide -Placentex Mastelli(Pdrn) for the Treatment of Diabetic Ulcers	Phase 4
Completed	`NCT03070938` - PuraPly™ Antimicrobial Wound Matrix and Wound Management	N/A
Recruiting	`NCT06031714` - Fetal Cell Receptors Repertoire	N/A
Completed	`NCT03286452` - The RESPOND Registry
Not yet recruiting	`NCT03046628` - Evaluation of Lower Extremity Tissue Perfusion With Polarized Laser Light	N/A
Terminated	`NCT00634868` - Treatment of Wounds Utilizing Light	N/A
Withdrawn	`NCT01353937` - Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers	Phase 1