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

Skin Ulcer Venous Stasis Chronic Clinical Trial

Official title: A Randomised Controlled Double Blind Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers in Conjunction With Standard Best Practice

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.

Clinical Trial Description

Patients will be screened for two weeks before enrollment to assess whether their ulcers are "non-healing", defined as a reduction in wound surface of < 25% after two weeks of standard best practice wound care . On enrolment and randomisation to active or placebo treatment the patient will be treated for six weeks or until 100% epithelialisation, whichever is the sooner, and then treatment will revert to standard best practice, defined as moist wound healing plus compression where appropriate. The reference ulcer will be followed up at two weeks and then at six weeks after the end of the active treatment period. ;

Related Conditions & MeSH terms

• Leg Ulcer
• Mixed Arteriovenous Leg Ulcer
• Skin Ulcer
• Skin Ulcer Venous Stasis Chronic
• Ulcer
• Varicose Ulcer

• NCT number: NCT01913704
• Study type: Interventional
• Source: Inotec AMD Limited
• Status: Withdrawn
• Phase: N/A
• Start date: October 2012
• Completion date: October 2014