The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT03905863|
Recruitment Status : Completed
First Posted : April 5, 2019
Last Update Posted : February 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer Surgical Wound||Device: Natrox® Oxygen Wound Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Multicentre Trial, Examining the Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers|
|Actual Study Start Date :||June 4, 2019|
|Actual Primary Completion Date :||October 18, 2020|
|Actual Study Completion Date :||October 18, 2020|
No Intervention: Standard of care arm
Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre.
Active Comparator: Intervention arm
Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound.
Device: Natrox® Oxygen Wound Therapy
A battery-operated device which delivers 98% pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.
- Percentage of wounds that heal [ Time Frame: Twelve (12) weeks from Time 0 ]Wounds will be visually assessed by clinicians as healed or not healed
- Wound size change [ Time Frame: Twelve (12) weeks from Time 0 ]Wound size change over time using a wound imaging measurement system
- Arbitrary scale of ease of implementation of Natrox® [ Time Frame: Twelve (12) weeks from Time 0 ]
Questionnaire to assess how easy or difficult clinicians found the addition of Natrox® to standard therapy regimens.
- Ease of application (1-5 scale)
- Ability to manage the wound effectively (1-5 scale)
- Ease of battery management by the patient (scale 1-5)
- Conformity to the wound bed (scale 1-5)
- Acceptance of the therapy by the patient (scale 1-5)
- Patient comfort (scale 1-5)
- overall impression (scale 1-5)
- Level of pain of the wound [ Time Frame: Twelve (12) weeks from Time 0 ]Does pain associated with the wound change over time using a Visual Analogue Scale Each study visit, patient wound pain will be assessed by asking the patient to rank their pain from the wound using a 1-10 scale
- Number of Dressing changes [ Time Frame: Twelve (12) weeks from Time 0 ]Number of dressing changes that are done on the study wound
- Number of adverse events [ Time Frame: Twelve (12) weeks from Time 0 ]Number of adverse events, such as infections, that are found associated with the study wound
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905863
|Study Director:||Thomas Serena||SerenaGroup, Inc.|