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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo device | Placebo Comparator | The placebo comparator is a placebo version of the active device which is a system to deliver oxygen from an oxygen generator topically to the wound bed via a proprietary device. The device will be applied to the wound and attached to the placebo oxygen generator and the generator switched on at the time of enrolment. Secondary dressings will then be applied. The device will be removed and reapplied at each dressing change for a treatment period of 6 weeks. |
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| NatroxTM Device | Active Comparator | A system to deliver oxygen from an oxygen generator topically to the wound via a proprietary device. The NatroxTM oxygen delivery device will be applied to the wound and attached to the NatroxTM oxygen generator which will be switched on at the time of first dressing application at enrolment. Secondary dressings will then be applied. The device will be removed and reapplied at each dressing change for a treatment period of 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NatroxTM Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the NatroxTM Topical Oxygen Device | 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. | Baseline at week 0 and then at 6 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the wound pain over the study duration | Measured using a validated Visual Analogue Scale ranging from 0 to 10 | Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks |
| Patient comfort with the device at dressing change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R Gurlich, Professor | Fakultni Nemocnice Kralovske Vinohrady Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery | Prague | 147 00 | Czechia | |||
| Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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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 |
| first removal of device and then on subsequent weekly changes |
| Patient acceptability of the device during wear | Patient questioned as to ability to mobilise, comfort of dressing and device and possible disturbance of sleep patterns, answers recorded as yes/no | Each weekly dressing change until week 6 |
| Statistical information from which to power a future large multi-centre randomised trial | 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. | Study End at week 12 |
| Efficiency of Exudate transportation through the device to the secondary dressing | Measured by the frequency of changes of the secondary dressing and by recording the incidence of maceration. | weekly up to week 6 (end of natrox treatment period) |
| Improvement in the wound bed during treatment with Natrox and Oxygen Delivery System (ODS) | Measured by visual assessment weekly by the Investigators | Baseline at week zero, weekly and end of treatment at week 6 |
| Reliability of the protocol | 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 | Study end follow up at week 12 |
| Monitor the safety of the device in use | Measured by recording the incidence and severity of adverse events as reported. | Study treatment end at week 6 and then until follow up at 12 weeks |
| Prague |
| Czechia |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |