The New NEAT study

• Research type

  Research Study

• Full title

  Prediction of healing of diabetic foot ulcers by the use of hyperspectral monitoring (HSM)

• IRAS ID

  164806

• Contact name

  William Jeffcoate

• Contact email

  william.jeffcoate@gmail.com

• Sponsor organisation

  Nottingham University Hospitals NHS Trust

• Duration of Study in the UK

  1 years, 3 months, 1 days

• Research summary

  People with a diabetic foot ulcer who are referred to one of two specialist centres will be invited to participate in a study designed to predict those that are unlikely to heal quickly. The study will attempt to confirm earlier work, but will differ by being undertaken with commercially available equipment. Prediction of healing will be based on the principle of hyperspectral imaging - whereby white light is shone at the skin and a handheld probe is used to assess the spectrum of refllected light. This spectrum is itself dependent on the oxygenation of haemoglobin in the tissues: the absortion of red and blue light will change with differing oxygenation. The earlier study of 43 people showed that this measure discriminated between those that did and did not heal within 12 weeks. If confirmed using a commercially available equipment featuring a simple handheld probe, this would be of considerable clinical importance because the early prediction of those less likely to heal would enable earlier and more targeted use of expensive invasive investiations sich as vascular and other imaging.

  The study will also seek to compare hyperspectral monitoring with other measures of peripheral limb blood flow: ankle brachial pressure index (ABPI), transcutaneous measurement of tissue oxygen (tcpO2) and laser Doppler assessment of blood cell flow (LDF).

  In addition participants will be separately asked to consent to having a blood sample taken from a vein of the foot. The aim of this is to assess the oxygation of venous blood and to confirm older work reporting that people with neuropathy have abnormal blood flow through the foot (arteriovenous shunting) - because such AV shunting could be an important factor contributing to decreased oxygen delivery to the tissues.
  Clinical importance

• REC name

  East Midlands - Nottingham 1 Research Ethics Committee

• REC reference

  15/EM/0117

• Date of REC Opinion

  24 Mar 2015

• REC opinion

  Favourable Opinion