Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
NCT ID: NCT04746573
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
8 participants
OBSERVATIONAL
2021-02-12
2022-05-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Natrox Topical Oxygen Therapy managed by telehealth
Pilot study using topical oxygen managed by telehealth in the home setting.
Natrox Topical Oxygen Therapy
Device delivering humidified oxygen directly to the wound bed
Interventions
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Natrox Topical Oxygen Therapy
Device delivering humidified oxygen directly to the wound bed
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Salem VA Medical Center
UNKNOWN
Inotec AMD Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Lee, DPM MS ABPM
Role: PRINCIPAL_INVESTIGATOR
US Dept of Veterans Affairs
Locations
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Salem VA Healthcare
Roanoke, Virginia, United States
Countries
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References
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Asmis R, Qiao M, Zhao Q. Low flow oxygenation of full-excisional skin wounds on diabetic mice improves wound healing by accelerating wound closure and reepithelialization. Int Wound J. 2010 Oct;7(5):349-57. doi: 10.1111/j.1742-481X.2010.00716.x.
Babior BM. Oxygen-dependent microbial killing by phagocytes (first of two parts). N Engl J Med. 1978 Mar 23;298(12):659-68. doi: 10.1056/NEJM197803232981205. No abstract available.
Knighton DR, Silver IA, Hunt TK. Regulation of wound-healing angiogenesis-effect of oxygen gradients and inspired oxygen concentration. Surgery. 1981 Aug;90(2):262-70.
4. Lordish, H. (2000) Molecular cell biology, Freeman, New York.
Sen CK. The general case for redox control of wound repair. Wound Repair Regen. 2003 Nov-Dec;11(6):431-8. doi: 10.1046/j.1524-475x.2003.11607.x.
Stephens FO, Hunt TK. Effect of changes in inspired oxygen and carbon dioxide tensions on wound tensile strength: an experimental study. Ann Surg. 1971 Apr;173(4):515-9. doi: 10.1097/00000658-197104000-00006. No abstract available.
Sundaresan M, Yu ZX, Ferrans VJ, Sulciner DJ, Gutkind JS, Irani K, Goldschmidt-Clermont PJ, Finkel T. Regulation of reactive-oxygen-species generation in fibroblasts by Rac1. Biochem J. 1996 Sep 1;318 ( Pt 2)(Pt 2):379-82. doi: 10.1042/bj3180379.
Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
Richmond NA, Maderal AD, Vivas AC. Evidence-based management of common chronic lower extremity ulcers. Dermatol Ther. 2013 May-Jun;26(3):187-96. doi: 10.1111/dth.12051.
Stockl K, Vanderplas A, Tafesse E, Chang E. Costs of lower-extremity ulcers among patients with diabetes. Diabetes Care. 2004 Sep;27(9):2129-34. doi: 10.2337/diacare.27.9.2129.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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Inotec AMD Inc
Identifier Type: -
Identifier Source: org_study_id
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