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

NCT01913704 | Withdrawn

• 1 other identifier: WMC16/CZ/12
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Skin Ulcer Venous Stasis Chronic; Mixed Arteriovenous Leg Ulcer

Keywords

venous leg ulcer; mixed aetiology leg ulcers

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change in the wound pain over the study duration

  Baseline at week 0, and then each weekly dressing change, 8 weeks and 12 weeks

• Patient comfort with the device at dressing change

  first removal of device and then on subsequent weekly changes

• Patient acceptability of the device during wear

  Each weekly dressing change until week 6

• Statistical information from which to power a future large multi-centre randomised trial

  Study End at week 12

• Efficiency of Exudate transportation through the device to the secondary dressing

  weekly up to week 6 (end of natrox treatment period)

Study Arms (2)

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.

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.

Device: NatroxTM Device

Interventions

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.

Also known as: NatroxTM ODS, NatroxTM Oxygen Generator

NatroxTM Device; Placebo device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inotec AMD Limited: lead

Study Sites (2)

Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery

Prague, 147 00, Czechia

Location

Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology

Prague, Czechia

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• R Gurlich, Professor

  Fakultni Nemocnice Kralovske Vinohrady Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: August 1, 2013
• Study Start: October 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CZ (2)