Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

October 31, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

October 31, 2014

Conditions
Skin Ulcer Venous Stasis ChronicMixed Arteriovenous Leg Ulcer
Interventions
DEVICE

NatroxTM Device

"The NatroxTM device is a system to deliver oxygen from an oxygen generator topically to the wound via a proprietary device.~The NatroxTM ODS oxygen delivery device will be applied to the wound and attached to the oxygen generator and switched on at the time of first dressing application at enrolment. Secondary dressings will then be applied. The oxygen delivery device will be removed and reapplied at each dressing change for a treatment period of 6 weeks."

Trial Locations (2)

147 00

Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery, Prague

Unknown

Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology, Prague

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Inotec AMD Limited

INDUSTRY

NCT01913704 - Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers | Biotech Hunter | Biotech Hunter