Clinical trial NCT01913704: Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Skin Ulcer Venous Stasis Chronic
Mixed Arteriovenous Leg Ulcer
Keywords: venous leg ulcer
mixed aetiology leg ulcers
Lead sponsor: Inotec AMD Limited
Sponsor class: INDUSTRY
First posted: 2013-08-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with superficial venous and mixed aetiology leg ulcers on a flat plane in surface area between 4-50cm2
* Patients with diabetes may be included providing they have good metabolic control
* Patients who understand the trial, agree to adhere to the treatment and are able to give consent
* Patients who can be followed by the same investigating team for the whole period of their participation in the study

Exclusion Criteria:

* Patients who present with wounds which are clinically infected and require antimicrobial therapy. Patients who have been treated for a wound infection with antimicrobial therapy (systematically or topically) may be included providing the wound is no longer assessed as infected and there is a two week wash-out period after the last treatment before the patient is reassessed against the inclusion and exclusion criteria
* Patients with a known sensitivity to any of the components of the evaluation device
* Patients with known or suspected malignancy in the wound or surrounding tissue
* Patients whose wounds show a percentage decrease in surface area of \>25% during the two week screening period
* Patients who do not have the physical or mental capacity, or a significant other with the ability to change the NatroxTM battery pack on a daily basis
* Patients who present with more than 10% of the wound surface area covered in hard eschar
* Patients who are actively treated with immunosuppressive or cortico-steroidal medication
* Patients who are participating in another clinical trial
* Patients with a known history or poor compliance with medical treatment
* Patients who have been in this trial previously and have withdrawn
* Patients who are unable to understand the aims of the trial and do not give informed consent

Primary outcomes:
measure: Effectiveness of the NatroxTM Topical Oxygen Device
timeFrame: Baseline at week 0 and then at 6 and 12 weeks
Secondary outcomes:
measure: Change in the wound pain over the study duration
timeFrame: Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks
measure: Patient comfort with the device at dressing change
timeFrame: first removal of device and then on subsequent weekly changes
measure: Patient acceptability of the device during wear
timeFrame: Each weekly dressing change until week 6
measure: Statistical information from which to power a future large multi-centre randomised trial
timeFrame: Study End at week 12
measure: Efficiency of Exudate transportation through the device to the secondary dressing
timeFrame: weekly up to week 6 (end of natrox treatment period)
measure: Improvement in the wound bed during treatment with Natrox and Oxygen Delivery System (ODS)
timeFrame: Baseline at week zero, weekly and end of treatment at week 6
measure: Reliability of the protocol
timeFrame: Study end follow up at week 12
measure: Monitor the safety of the device in use
timeFrame: Study treatment end at week 6 and then until follow up at 12 weeks
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery
city: Prague
country: Czechia
facility: Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology
Study officials:
affiliation: Fakultni Nemocnice Kralovske Vinohrady Prague
name: R Gurlich, Professor
role: PRINCIPAL_INVESTIGATOR
References: