Effect of Natrox Oxygen Wound Therapy on Non-healing Wounds and Implication of Remote Monitoring and Telehealth for Management in the Home.

NCT04746573 | Completed FDA Device

• 1 other identifier: Inotec AMD Inc
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-healing Wounds

Keywords

Diabetic foot ulcers; Venous leg ulcers; Pressure injuries; Surgical wounds

Outcome Measures

Primary Outcomes (1)

• Number of participants that achieve complete wound closure.

  Percentage change in ulcer size relative to baseline measurement

  12 weeks

Other Outcomes (1)

• Effectiveness 0f remote management and telehealth

  12 weeks

Study Arms (1)

Natrox Topical Oxygen Therapy managed by telehealth

Pilot study using topical oxygen managed by telehealth in the home setting.

Device: Natrox Topical Oxygen Therapy

Interventions

Natrox Topical Oxygen Therapy DEVICE

Device delivering humidified oxygen directly to the wound bed

Natrox Topical Oxygen Therapy managed by telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-healing wounds of not less than 4 weeks and not greater than 12 months.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inotec AMD Limited: lead
• Salem VA Medical Center: collaborator

Study Sites (1)

Salem VA Healthcare

Roanoke, Virginia, 24153, United States

Location

Related Publications (10)

• 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.

  PMID: 20659184 BACKGROUND

• 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.

  PMID: 24176 BACKGROUND

• 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.

  PMID: 6166996 BACKGROUND

• 4. Lordish, H. (2000) Molecular cell biology, Freeman, New York.

  BACKGROUND

• 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.

  PMID: 14617282 BACKGROUND

• 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.

  PMID: 5573643 BACKGROUND

• 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.

  PMID: 8809022 BACKGROUND

• 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.

  PMID: 26339534 BACKGROUND

• 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.

  PMID: 23742279 BACKGROUND

• 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.

  PMID: 15333473 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Pressure Ulcer; Surgical Wound

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Wounds and Injuries

Study Officials

• Dr Lee, DPM MS ABPM

  US Dept of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 10, 2021
• Study Start: February 12, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)