Status:
COMPLETED
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
Lead Sponsor:
Inotec AMD Limited
Collaborating Sponsors:
Salem VA Medical Center
Conditions:
Non-healing Wounds
Eligibility:
All Genders
18+ years
Brief Summary
Single center pilot study examining the effect of Natrox topical oxygen therapy on chronic wounds along with the introduction of remote monitoring and telehealth for home care management.
Detailed Description
There is a wealth of evidence to support the benefits of oxygen therapy on wound healing. Oxygen is required for all major processes of wound healing and wound hypoxia is common. Skin wounds can recei...
Eligibility Criteria
Inclusion
- Subject having non-healing wound of any etiology except for 3rd degree burns
- No visible improvement in the previous 4 weeks.
- Wound present for at least 4 weeks but less than 12 months.
- Subjects wound is not less that 1 cm sq or greater than 25 cm sq
- Subject is able and willing to participate in self care
- Subject is able and willing to follow protocol requirements
- Subject has signed informed consent
Exclusion
- Subject has life expectancy of \<1 year
- Subject is unable to manage the Natrox device.
- Subject unable or reluctant to use Iphone and imaging technology
- Subjects ulcers are 100% necrotic or if physician felt it necessary to completely cover the wound with creams or gels that would prevent the transmission of oxygen to the wound base.
- Subject has major uncontrolled medical disorder(s) such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
- Subject is currently being treated for active malignant disease or patients with history of malignancy within the wound
- Subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
- Known contraindications to Natrox
- Known allergies to any fo the Natrox components
- Known allergies to adhesives
Key Trial Info
Start Date :
February 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 15 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04746573
Start Date
February 12 2021
End Date
May 15 2022
Last Update
September 28 2023
Active Locations (1)
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1
Salem VA Healthcare
Roanoke, Virginia, United States, 24153