Non-healing WoundsNCT04746573
Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.
An observational study of Non-healing Wounds, run by Inotec AMD Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-healing Wounds
- What is being tested?
- Natrox Topical Oxygen Therapy
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2021to 15 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with non-healing wounds of not less than 4 weeks and not greater than 12 months.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Non-healing Wounds
- Being tested
- Natrox Topical Oxygen Therapy
- Keywords
- Diabetic foot ulcers, Venous leg ulcers, Pressure injuries, Surgical wounds
- Medical subject headings
- Diabetic Foot, Pressure Ulcer, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natrox Topical Oxygen TherapyDevice
Device delivering humidified oxygen directly to the wound bed
| Study group | Role | What they receive |
|---|---|---|
| Natrox Topical Oxygen Therapy managed by telehealth | Pilot study using topical oxygen managed by telehealth in the home setting. Receives: Device: Natrox Topical Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that achieve complete wound closure.
Percentage change in ulcer size relative to baseline measurement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start12 Feb 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Non-healing WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inotec AMD Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Salem VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Dr Lee, DPM MS ABPM, Principal investigator, US Dept of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746573
- Sponsor's protocol ID
- Inotec AMD Inc
- Status last verified
- Sep 2023
- First submitted
- 26 Jan 2021
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 20659184Babior 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.
PubMed 24176Knighton 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.
PubMed 61669964. 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.
PubMed 14617282Stephens 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.
PubMed 5573643Sundaresan 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.
PubMed 8809022Frykberg 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.
PubMed 26339534Richmond 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.
PubMed 23742279Stockl 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.
PubMed 15333473
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04746573
- Acronym / sponsor ID
- Inotec AMD Inc
- Conditions
- Non-healing Wounds
- Keywords
- Diabetic foot ulcers, Venous leg ulcers, Pressure injuries, Surgical wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Inotec AMD LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Salem VA Medical Center
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natrox Topical Oxygen Therapy managed by telehealth | – | Device: Natrox Topical Oxygen TherapyPilot study using topical oxygen managed by telehealth in the home setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-healing wounds of not less than 4 weeks and not greater than 12 months.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natrox Topical Oxygen TherapyDevice delivering humidified oxygen directly to the wound bed | Device | Natrox Topical Oxygen Therapy managed by telehealth |
Primary outcome
Number of participants that achieve complete wound closure.
Time frame: 12 weeks
Percentage change in ulcer size relative to baseline measurement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 20659184Asmis 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.
- Background: PubMed 24176Babior 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.
- Background: PubMed 6166996Knighton 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.
- Background4. Lordish, H. (2000) Molecular cell biology, Freeman, New York.
- Background: PubMed 14617282Sen 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.
- Background: PubMed 5573643Stephens 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.
- Background: PubMed 8809022Sundaresan 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.
- Background: PubMed 26339534Frykberg 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.
- Background: PubMed 23742279Richmond 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.
- Background: PubMed 15333473Stockl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Lee, DPM MS ABPM principal investigator
US Dept of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-healing Wounds, run by Inotec AMD Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that achieve complete wound closure. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746573, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.