Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746573
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2021-01-26
Brief Title:
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home
Sponsor:
Inotec AMD Limited
Organization:
Inotec AMD Limited
Study Overview
Official Title:
A Single Center Pilot Study to Examine the Effect of NATROX Oxygen Wound Therapy on Non-healing Wounds and the Practical Implication of Introducing a Remote Monitoring and Telehealth Solution to Manage These Complex Patients in the Home Setting
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 wounds 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 andor 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 VAs strategy to protect and care for Veterans their families heath care providers and staff in the face of this pandemic
The VAs tactic to shift outpatient care to a telehealth mode with phone video andor 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
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 andor 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 VAs strategy to protect and care for Veterans their families heath care providers and staff in the face of this pandemic
The VAs tactic to shift outpatient care to a telehealth mode with phone video andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None