New Study Demonstrates Significantly Increased Healing Rates with NATROX® O₂

Treatment offers hope for patients with long-standing chronic wounds


[Cambridge, UK – 17 May 2021] – Inotec AMD, manufacturer of NATROX® Oxygen Wound Therapy, is delighted to share newly published randomised controlled trial (RCT) results1. The trial involved 145 patients with previously non-healing diabetic foot ulcers (DFUs) and compared the effects of using standard care against a combination of standard care plus NATROX® Oxygen Wound Therapy. Patients completing the therapy experienced 71% greater healing rates and 73% greater reduction in wound size using NATROX®. These results offer hope to patients suffering from chronic wounds.

What is NATROX®
NATROX® Oxygen Wound Therapy is a class II medical device that uses the natural healing properties of oxygen. The product was designed specifically to heal chronic wounds. Originally invented by the company’s founder to aid a family member enduring severe pain from a non-healing ulcer, Inotec was established to transform the quality of life for patients with chronic wounds through its innovative topical oxygen therapy. The NATROX® device is small, silent, and completely portable which means patients receive treatment 24/7, leading to better healing outcomes.

About the study
Inotec sponsored the study to investigate the impact of NATROX® on previously non-healing DFUs. The study included 19 sites in the USA and involved 145 patients, with 54% of patients over age 65. The study’s Principal Investigator, Dr. Thomas Serena, is an internationally recognized expert in wound healing. Serena is former President of the American Professional Wound Care Association and current CEO of the SerenaGroup®, a leading provider of wound care. Eligible patients in the trial had a chronic wound for an average of 23-24 weeks before entering a 12-week therapy period, and over half the participants in the NATROX® group had a history of prior amputation. It is worth noting, the study continuing despite new COVID-19 protocols indicates the ease and simplicity of treatment.

Innovative use of AI
During the trial, wounds were measured using an artificial intelligence (AI) tool to reduce study bias and assure measurement consistency across sites. Clinicians took photos of the wound, then the AI program automatically identified wound size and tracked healing rates.

Study results
Over 52% of NATROX® treated patients healed within the 12-week therapy period, representing a 71% greater healing rate and 73% greater reduction in wound size compared to the control group. Study investigators concluded using NATROX® leads to statistically significant improved healing rates in patients with chronic wounds. Investigators also noted using topical oxygen therapy that is easily maintained in home settings can reduce the financial burden of wound care in the long term.

High costs
Thefinancialcosts of managing DFUs are well established2,3,4; however, the greatest cost is the impact on patient’s quality of life and mortality. Not only do patients experience reduced mobility, loss of independence, and ongoing clinical intervention, many report pain levels that negatively impact daily activities and sleep5.

Why it matters
Diabetes is on the rise, and it is predicted that 1 in 3 adults in the USA will be diabetic by 20506, with 1 in 4 developing a DFU during their lifetime2. 50% of all DFUs become infected and 20% end in amputation3. Sadly, half of patients who undergo amputation die within 5 years4; therefore, finding a successful treatment option is critical. The study indicates NATROX® Oxygen Wound Therapy is poised to become the new standard in wound care and gives hope to patients suffering long-standing wounds.


References

  1. Serena TE, Bullock NM, Cole W et al. Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled trial. J Wound Care 2021; 30: Suppl.5 S7-14.
  2. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med 2017; 376: 2367-75.
  3. Wu S, Driver VR, Wrobel JS et al (2007) Foot ulcers in the diabetic patient, prevention and treatment. Vasc Health Risk Manag 3(1): 65–76.
  4. Brennan MB, Hess TM, Bartle B et al (2017) Diabetic foot ulcer severity predicts mortality among veterans with type 2 diabetes. J Diabet Complications 31(3): 556-61.
  5. Bradbury S, Price P (2011) The impact of diabetic foot ulcer pain on patient quality of life. Wounds UK 7(4): 32-49.
  6. World Health Organisation (2016) Global Report on Diabetes. WHO, Geneva, Switzerland. Available at: https://bit.ly/2HQbtiF (accessed 03.06.19).

About Inotec AMD, Ltd.

Inotec AMD Ltd is a specialist wound care company based in Cambridge, England. Formed specifically to introduce new technologies to healthcare professionals worldwide and promote faster, better healing to patients, the company is positioning NATROX® to be an integral part of global wound care treatment regimes in the coming years. To learn more, visit: natroxwoundcare.com.

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