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

NCT ID: NCT01913704

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-10-31

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.

Conditions

Skin Ulcer Venous Stasis Chronic; Mixed Arteriovenous Leg Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

NatroxTM Device

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

NatroxTM Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

NatroxTM ODS; NatroxTM Oxygen Generator

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 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inotec AMD Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R Gurlich, Professor

Role: PRINCIPAL_INVESTIGATOR

Fakultni Nemocnice Kralovske Vinohrady Prague

Locations

Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery

Prague, , Czechia

Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology

Prague, , Czechia

Countries

Czechia

Other Identifiers

WMC16/CZ/12

Identifier Type: -

Identifier Source: org_study_id