- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04746573
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Virginia
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Roanoke, Virginia, United States, 24153
- Salem VA Healthcare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Natrox Topical Oxygen Therapy managed by telehealth
Pilot study using topical oxygen managed by telehealth in the home setting.
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Device delivering humidified oxygen directly to the wound bed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants that achieve complete wound closure.
Time Frame: 12 weeks
|
Percentage change in ulcer size relative to baseline measurement
|
12 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness 0f remote management and telehealth
Time Frame: 12 weeks
|
Change in number of face to face clinic visits necessary
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr Lee, DPM MS ABPM, US Dept of Veterans Affairs
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Inotec AMD Inc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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