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Trial record 5 of 159 for:    Open Studies | "Leg Ulcer"

Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Inotec AMD Limited
Sponsor:
Information provided by (Responsible Party):
Inotec AMD Limited
ClinicalTrials.gov Identifier:
NCT01913704
First received: January 28, 2013
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Skin Ulcer Venous Stasis Chronic
Mixed Arteriovenous Leg Ulcer
Device: NatroxTM Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Inotec AMD Limited:

Primary Outcome Measures:
  • Effectiveness of the NatroxTM Topical Oxygen Device [ Time Frame: Baseline at week 0 and then at 6 and 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks ] [ Designated as safety issue: No ]
    Measured using a validated Visual Analogue Scale ranging from 0 to 10

  • Patient comfort with the device at dressing change [ Time Frame: first removal of device and then on subsequent weekly changes ] [ Designated as safety issue: No ]
    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 [ Time Frame: Each weekly dressing change until week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Study End at week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: weekly up to week 6 (end of natrox treatment period) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline at week zero, weekly and end of treatment at week 6 ] [ Designated as safety issue: No ]
    Measured by visual assessment weekly by the Investigators

  • Reliability of the protocol [ Time Frame: Study end follow up at week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Study treatment end at week 6 and then until follow up at 12 weeks ] [ Designated as safety issue: Yes ]
    Measured by recording the incidence and severity of adverse events as reported.


Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo device

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.

Device: NatroxTM 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.

Other Names:
  • NatroxTM ODS
  • NatroxTM Oxygen Generator
Active Comparator: NatroxTM Device

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.

Device: NatroxTM 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.

Other Names:
  • NatroxTM ODS
  • NatroxTM Oxygen Generator

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913704

Contacts
Contact: R Gurlich, Professor +4200267162412 gurlich@fnkv.cz

Locations
Czech Republic
Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology Recruiting
Prague, Czech Republic
Contact: R Gurlich, Professor         
Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery Recruiting
Prague, Czech Republic, 147 00
Contact: R Gurlich, Professor    +4200267162412      
Sponsors and Collaborators
Inotec AMD Limited
Investigators
Principal Investigator: R Gurlich, Professor Fakultni Nemocnice Kralovske Vinohrady Prague
  More Information

No publications provided

Responsible Party: Inotec AMD Limited
ClinicalTrials.gov Identifier: NCT01913704     History of Changes
Other Study ID Numbers: WMC16/CZ/12
Study First Received: January 28, 2013
Last Updated: August 1, 2013
Health Authority: Czech Republic: Ethics Committee

Keywords provided by Inotec AMD Limited:
venous leg ulcer
mixed aetiology leg ulcers

Additional relevant MeSH terms:
Leg Ulcer
Postphlebitic Syndrome
Postthrombotic Syndrome
Skin Ulcer
Ulcer
Varicose Ulcer
Cardiovascular Diseases
Embolism and Thrombosis
Pathologic Processes
Peripheral Vascular Diseases
Phlebitis
Skin Diseases
Thrombosis
Varicose Veins
Vascular Diseases
Venous Insufficiency
Venous Thrombosis

ClinicalTrials.gov processed this record on November 20, 2014