Status:
WITHDRAWN
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing Leg Ulcers
Lead Sponsor:
Inotec AMD Limited
Conditions:
Skin Ulcer Venous Stasis Chronic
Mixed Arteriovenous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 practic...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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- Patients who have been in this trial previously and have withdrawn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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01913704
Start Date
October 1 2012
End Date
October 1 2014
Last Update
March 18 2020
Active Locations (2)
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1
Fakultni Nemocnice Kralovske Vinohrady, Clinical of Surgery
Prague, Czechia, 147 00
2
Fakultni Nemocnice Kralovkse Vinohrady, Clinic of Dermatology
Prague, Czechia