NCT02046226

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Halyard Health · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
DEVICE	Oxygenesys(TM) Dissolved Oxygen Dressing	OxyGenesys(TM) Dissolved Oxygen Dressing

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-01-27
• Last updated: 2015-10-12
• Results posted: 2015-10-12

Locations

1 site across 1 country: United States