Skin Ulcer Venous Stasis ChronicNCT01913704
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
A study testing NatroxTM Device in people with Skin Ulcer Venous Stasis Chronic and Mixed Arteriovenous Leg Ulcer, run by Inotec AMD Limited at 2 sites in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Ulcer Venous Stasis Chronic, Mixed Arteriovenous Leg Ulcer
- What is being tested?
- NatroxTM Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesCzechia
- Study dates
- Oct 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery
Prague, 147 00
Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology
Prague
About this study
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
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.
Read the 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.
- Being tested
- NatroxTM Device
- Keywords
- venous leg ulcer, mixed aetiology leg ulcers
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatroxTM DeviceDevice
Also called NatroxTM ODS, NatroxTM Oxygen Generator
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NatroxTM Device |
| 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. Receives: Device: NatroxTM Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline at week 0 and then at 6 and 12 weeks
Secondary outcomes (8)
Change in the wound pain over the study duration
Measured using a validated Visual Analogue Scale ranging from 0 to 10
Measured: Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks
Patient comfort with the device at dressing change
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Study treatment end at week 6 and then until follow up at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: Company turnover
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Ulcer Venous Stasis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inotec AMD Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- R Gurlich, Professor, Principal investigator, Fakultni Nemocnice Kralovske Vinohrady Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913704
- Sponsor's protocol ID
- WMC16/CZ/12
- Status last verified
- Mar 2020
- First submitted
- 28 Jan 2013
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01913704
- Acronym / sponsor ID
- WMC16/CZ/12
- Keywords
- venous leg ulcer, mixed aetiology leg ulcers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company turnover
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inotec AMD LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo device | Placebo comparator | Device: NatroxTM DeviceThe 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. |
| NatroxTM Device | Active comparator | Device: NatroxTM DeviceA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatroxTM DeviceAlso: NatroxTM ODS, NatroxTM Oxygen GeneratorThe 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. | Device | NatroxTM Device, Placebo device |
Primary outcome
Effectiveness of the NatroxTM Topical Oxygen Device
Time frame: 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.
8 secondary outcomes
Change in the wound pain over the study duration
Time frame: Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks
Patient comfort with the device at dressing change
Time frame: first removal of device and then on subsequent weekly changes
Patient acceptability of the device during wear
Time frame: Each weekly dressing change until week 6
Statistical information from which to power a future large multi-centre randomised trial
Time frame: Study End at week 12
Efficiency of Exudate transportation through the device to the secondary dressing
Time frame: weekly up to week 6 (end of natrox treatment period)
Improvement in the wound bed during treatment with Natrox and Oxygen Delivery System (ODS)
Time frame: Baseline at week zero, weekly and end of treatment at week 6
Reliability of the protocol
Time frame: Study end follow up at week 12
Monitor the safety of the device in use
Time frame: Study treatment end at week 6 and then until follow up at 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Gurlich, Professor principal investigator
Fakultni Nemocnice Kralovske Vinohrady Prague
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NatroxTM Device in people with Skin Ulcer Venous Stasis Chronic and Mixed Arteriovenous Leg Ulcer, run by Inotec AMD Limited at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the NatroxTM Topical Oxygen Device (time frame: Baseline at week 0 and then at 6 and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.