Back to resultsPilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
Primary Purpose
Skin Ulcer Venous Stasis Chronic, Mixed Arteriovenous Leg Ulcer
Status
Withdrawn
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
NatroxTM Device
Sponsored by
About this trial
This is an interventional treatment trial for Skin Ulcer Venous Stasis Chronic focused on measuring venous leg ulcer, mixed aetiology leg ulcers
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- Patients who have been in this trial previously and have withdrawn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
Sites / Locations
- Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery
- Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo device
NatroxTM Device
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in the wound pain over the study duration
Measured using a validated Visual Analogue Scale ranging from 0 to 10
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
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
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.
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.
Improvement in the wound bed during treatment with Natrox and Oxygen Delivery System (ODS)
Measured by visual assessment weekly by the Investigators
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
Monitor the safety of the device in use
Measured by recording the incidence and severity of adverse events as reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01913704
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Company turnover
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inotec AMD Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Ulcer Venous Stasis Chronic, Mixed Arteriovenous Leg Ulcer
Keywords
venous leg ulcer, mixed aetiology leg ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo device
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
NatroxTM Device
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NatroxTM Device
Other Intervention Name(s)
NatroxTM ODS, NatroxTM Oxygen Generator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of the NatroxTM Topical Oxygen Device
Description
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.
Time Frame
Baseline at week 0 and then at 6 and 12 weeks
Secondary Outcome Measure Information:
Title
Change in the wound pain over the study duration
Description
Measured using a validated Visual Analogue Scale ranging from 0 to 10
Time Frame
Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks
Title
Patient comfort with the device at dressing change
Description
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
Time Frame
first removal of device and then on subsequent weekly changes
Title
Patient acceptability of the device during wear
Description
Patient questioned as to ability to mobilise, comfort of dressing and device and possible disturbance of sleep patterns, answers recorded as yes/no
Time Frame
Each weekly dressing change until week 6
Title
Statistical information from which to power a future large multi-centre randomised trial
Description
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.
Time Frame
Study End at week 12
Title
Efficiency of Exudate transportation through the device to the secondary dressing
Description
Measured by the frequency of changes of the secondary dressing and by recording the incidence of maceration.
Time Frame
weekly up to week 6 (end of natrox treatment period)
Title
Improvement in the wound bed during treatment with Natrox and Oxygen Delivery System (ODS)
Description
Measured by visual assessment weekly by the Investigators
Time Frame
Baseline at week zero, weekly and end of treatment at week 6
Title
Reliability of the protocol
Description
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
Time Frame
Study end follow up at week 12
Title
Monitor the safety of the device in use
Description
Measured by recording the incidence and severity of adverse events as reported.
Time Frame
Study treatment end at week 6 and then until follow up at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Gurlich, Professor
Organizational Affiliation
Fakultni Nemocnice Kralovske Vinohrady Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery
City
Prague
ZIP/Postal Code
147 00
Country
Czechia
Facility Name
Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology
City
Prague
Country
Czechia
12. IPD Sharing Statement
Learn more about this trial
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
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