Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-05 @ 6:17 PM
Study NCT ID:
NCT01913704
Status:
WITHDRAWN
Last Update Posted:
2020-03-18
First Post:
2013-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
Sponsor:
Inotec AMD Limited
Organization:
Study Overview
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WITHDRAWN
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company turnover
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: