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Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Official title:
A Prospective, Randomized, Single-center Pilot Study of the OxyGenesys™ Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia

Clinical Trial Summary

A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.

Clinical Trial Description

A Prospective, Randomized, controlled pilot study enrolling up to 50 subjects at a singe investigational site in the US. Subjects with atherosclerotic peripheral arteria disease (PAD) presenting with critical limb ischemia (CLI) and one or more non-healing lower extremity arterial insufficiency ulcers who are suitable candidates for revascularization procedures (endovascular or surgical) will be randomized 1:1 to:

- Wound care with the use of OxyGenesys(TM) Dissolved Oxygen Dressing, or

- Standard Wound Care procedures

An initial study phase will enroll up to 20 subjects (10 in each arm). Pending results of the initial study phase, the study may continue to enroll until up to 50 subjects (25 in each arm) have been enrolled.

All subjects will be followed clinically and receive wound evaluation at 1, 3, and 6 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02046226
Study type Interventional
Source Halyard Health
Contact
Status Terminated
Phase N/A
Start date August 2013
Completion date May 2014
View Details
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