An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title: An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers

Status Completed

Clinical Trial Summary

This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks. If the wound is not reduced by more than 40%, NATROX™ will be applied for the next 12 weeks. Throughout the study period, wound measurements will be taken to measure wound reduction.

Clinical Trial Description

Diabetes and its attendant complications are increasing year on year. A number of macro- and micro-circulatory changes occur as a result of long standing or poorly controlled diabetes. These, often in association with either loss of lower limb sensation, or mechanical changes in the foot architecture, can lead to the formation of foot ulcers. These can be hard to heal because of the changes in the diabetic foot described above, as well as an increased incidence of infection in this population. Invasive or ascending infection through these breaks in the skin can lead to tissue loss, which may range from a single toe to major amputation below or above the knee. Major limb amputation has a profound effect on patient's quality of life, as well as a significant economic impact on the health and social care budget. Caring for diabetic foot ulcers, and the complications of this, have a cost of around S$1.2 billion per annum, which has become a focus of public health concern in Singapore recently.

The concept of increasing the oxygen concentration in healing wounds developed originally with hyperbaric oxygen therapy, and from the fact that oxygen is one of the most essential elements used during cellular metabolism. Poor tissue oxygenation, as is often seen in diabetic foot ulcers, is a significant impediment to cellular activity, and is therefore very likely to impair wound healing.

The NATROX™ topical oxygen therapy system developed by Inotec AMD Limited employs a small battery-powered electrochemical "oxygen generator" to concentrate atmospheric oxygen and feed the pure, moist, oxygen at a rate of around 13ml/hour through a fine, soft, tube to a dressing-like "oxygen distribution system" that is placed over the wound and is held in place by a conventional dressing. The oxygen generator is worn in a holster on the waist or above the calf, or is placed in a trouser pocket, thus enabling the patient to enjoy normal mobility (hence "ambulatory") while receiving continuous treatment.

The very significant costs of treatment of diabetic foot ulcers and the impact of amputations on quality of life and life expectancy, suggest that Natrox™ treatment is likely to be cost effective, a conclusion that was evident from the brief independent health economics study linked to the project. To date, no Asian study looking at whether the device is efficacious in a multi-racial population like Singapore. The vessels in Asians are generally smaller and the micro circulation is generally more diseased than our Caucasian counterparts because of the higher incidence of diabetes. This technology could be ideal for such patients and improve our limb salvage rates. After revascularization and control of infection, there is little alternative if the wound does not heal apart from further wound debridement or major amputation. This study may show us which Diabetic Foot Ulcers or wounds are likely to respond to topical oxygen and what effect it has on the patient per se in terms of pain relief and improvement of quality of life. ;

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Non-healing Wound
• Ulcer

• NCT number: NCT03863054
• Study type: Observational
• Source: Singapore General Hospital
• Status: Completed
• Start date: August 17, 2018
• Completion date: May 31, 2021