Mixed Arteriovenous Leg Ulcer, Skin Ulcer Venous Stasis Chronic
Conditions
Keywords
venous leg ulcer, mixed aetiology leg ulcers
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.
Interventions
DEVICENatroxTM 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.
Sponsors
Inotec AMD Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the NatroxTM Topical Oxygen Device | Baseline at week 0 and then at 6 and 12 weeks | Effectiveness of the NatroxTM Topical Oxygen Device will be established vs. Placebo in patients with non-healing leg ulceration in conjunction with best practice. Effectiveness will measured by the absolute and relative change in wound surface area as measured by digital photography and wound-mapping software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient comfort with the device at dressing change | first removal of device and then on subsequent weekly changes | Patient will be recorded on each visit with the dressing applied and will be recorded as a yes/no to comfort experienced by the patients |
| Patient acceptability of the device during wear | Each weekly dressing change until week 6 | Patient questioned as to ability to mobilise, comfort of dressing and device and possible disturbance of sleep patterns, answers recorded as yes/no |
| Statistical information from which to power a future large multi-centre randomised trial | Study End at week 12 | Statistical information on use of Natrox device and effectiveness on patients. Wound surface area will be measured in square centimetres as defined by wound mapping software. The wound surface area reduction between six weeks and baseline will then be calculated. Wound surface area will be measured at weekly intervals for the 6 weeks of active treatment and then at weeks 8 and 12 for follow up. The primary analysis will be an intent-to-treat analysis. A two-sided significance level of 0.05 will be used for all analyses. A general linear model taking into account the treatment groups and centres (surgical and dermatology clinics) as fixed effects and a baseline wound surface area as a covariate will be used to test the null hypothesis of similar effects in surface area reduction between treatment groups. |
| Change in the wound pain over the study duration | Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks | Measured using a validated Visual Analogue Scale ranging from 0 to 10 |
| Improvement in the wound bed during treatment with Natrox and Oxygen Delivery System (ODS) | Baseline at week zero, weekly and end of treatment at week 6 | Measured by visual assessment weekly by the Investigators |
| Reliability of the protocol | Study end follow up at week 12 | The reliability of the protocol will be determined by ability to implement it in the clinical setting effectively and the accuracy of the outcomes delivered from the study |
| Monitor the safety of the device in use | Study treatment end at week 6 and then until follow up at 12 weeks | Measured by recording the incidence and severity of adverse events as reported. |
| Efficiency of Exudate transportation through the device to the secondary dressing | weekly up to week 6 (end of natrox treatment period) | Measured by the frequency of changes of the secondary dressing and by recording the incidence of maceration. |
Countries
Czechia
Outcome results
None listed