An observational study in Non-healing Wounds, sponsored by Inotec AMD Limited. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Inotec AMD Limited · Observational
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.
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 receive oxygen from the blood stream via perfusion and from oxygen uptake through the skin. Yet, both wound perfusion and blood oxygen levels are frequently insufficient in patients with chronic wounds due to poor circulation, vascular disruption, and vasoconstriction, thereby reducing the wound's capacity to heal.
Diabetic ulcers, vascular ulcers (venous or arterial), and pressure injuries are all chronic wounds. The pathologies underlying chronic wounds can differ widely. However, common shared features include prolonged or excessive inflammation, persistent infections, and the inability to respond to reparative stimuli. Adults with vascular disease and/or diabetes are at highest risk for chronic leg and foot wounds. The ischemic (reduced tissue perfusion) and/ or hypoxic lower limb conditions which result from these conditions reduces availability of both oxygen and nutrients, making these wounds especially hard to heal. These wounds last on average 12 to 13 months, but this varies widely; many will remain open for years or never heal, and up to 30% of DFUs go onto amputation. Even when they do heal, wounds recur in 60-70% of patients, decrease quality of life, and are a significant cause of morbidity.
The need for telehealth and remote patient monitoring in the current climate is critical and reinforces the VA's strategy to protect and care for Veterans, their families, heath care providers and staff in the face of this pandemic.
The VA's tactic to shift outpatient care to a "telehealth" mode, with phone, video and/or electronic communication to meet the needs of the ambulatory patient is difficult to achieve in wound care as clinicians rely heavily on the visual appearance of the wound to direct their therapy decisions. Thus, it is imperative to validate a remote monitoring tool that offers standard telehealth care as well as accurate, consistent, and simple wound measurement and imagery. Having the ability to manage complex wounds accurately should enable quick identification of early warning signs that the wound is deteriorating thus facilitating appropriate triaging of patients that need urgent face to face medical review.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 8 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Inotec AMD Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with non-healing wounds of not less than 4 weeks and not greater than 12 months.
Exclusion Criteria:
Pilot study using topical oxygen managed by telehealth in the home setting.
Device: Natrox Topical Oxygen Therapy
Device delivering humidified oxygen directly to the wound bed
Number of participants that achieve complete wound closure.
Percentage change in ulcer size relative to baseline measurement
Time frame: 12 weeks
Effectiveness 0f remote management and telehealth
Change in number of face to face clinic visits necessary
Time frame: 12 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Inotec AMD Limited