Topical Oxygen and Diabetic Foot Ulcers 2 (TODFU2)

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo controlled multicenter trial, examining the effect of Natrox™ on the rates of healing for chronic diabetic foot ulcers.

• IRAS ID

  166923

• Contact name

  Paul Hayes

• Contact email

  paul.hayes@addenbrookes.nhs.uk

• Sponsor organisation

  Intoec AMD Ltd

• Duration of Study in the UK

  0 years, 10 months, 30 days

• Research summary

  Tissue oxygenation plays a vital role in the healing process. It contributes to angiogenesis (growth of new blood vessels), the development of the extra­cellular matrix and cell motility within the wound healing process. (Gordillo et al, 2003). Many wounds fail to heal because of inadequate oxygen levels. Diabetic foot wounds that fail to heal place their sufferers at risk of amputation.

  The most widespread method of increasing oxygen delivery to wounds to date has been the use of hyperbaric chambers for wounds where there is poor perfusion. These are expensive and therapy time consuming with potential side effects and complications and their use is not common in Europe. (Wright, 2001), (Ma et al, 2013).
  The Natrox™ system is a device designed to overcome a number of problems associated with previous methods of oxygen therapy, by delivering continuous oxygen to the wound bed through a dressing. It consists of a small rechargable, battery­-powered oxygen concentrator which processes oxygen from air and which because of its size and weight is portable and can be held in place by a lightweight strap. It has a very high level of acceptibilty with patients when piloted. The phase 1 study showed that over an 8 week period there was a reduction of around 50% in the size of some chronic hard to heal diabetic foot wounds.

  This proposed randomised, double blind, placebo controlled multicentre study will contribute to the understanding of the management of these wounds by reviewing the reductions in wound size achieved using Natrox™ topical oxygen therapy.

  The device will be insitu for up to 24 weeks and as well as confirming whether the device is clinically effective, we will also study its cost-effectiveness too.

  The study will recruit up to 140 male and female subjects in group 1 and 42 male or female subjects in group 2.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  15/EM/0021

• Date of REC Opinion

  28 Jan 2015

• REC opinion

  Further Information Favourable Opinion