TRAnscutaneous oxygen Measurement and diabetic foot ULceration: TRAMUL
Research type
Research Study
Full title
A pilot study of TRAnscutaneous oxygen Measurement and diabetic foot ULceration: TRAMUL
IRAS ID
136125
Contact name
Cliff Murch
Contact email
Sponsor organisation
NHS Lanarkshire
Research summary
Diabetic foot ulcers often develop after minor trauma, such as stubbing a toe or soft tissue injury when trimming nails. They are often indolent, requiring intensive treatment from Podiatry, causing considerable discomfort and inconvenience to the patient and costing the NHS a lot of money.
The ulcers occur in diabetic patients particularly due to a variable combination of neuropathy and vascular insufficiency. The neuropathy causes numbness of the toes or feet and the patient is unaware of skin injury. The vascular insufficiency results in delayed or failure to heal. If the vascular disease is severe enough, skin breakdown may occur without injury.
Transcutaneous Oxygen Monitoring (TcOM) is a non-invasive method of measuring the oxygen concentration (p02 in mmHg) in the subcutaneous tissues, using adherent cutaneous pads providing an objective measurement of perfusion and oxygenation.
The aim of the pilot study is to determine whether Transcutaneous Oxygen Monitoring can identify diabetic patients with foot ulcers that have sub-clinical Critical Limb Ischaemia.
If the pilot is successful, the aim of a full, follow-up study will be to demonstrate whether Transcutaneous Oxygen Monitoring can reduce the number of patients undergoing inappropriate conservative treatment, ensuring patients are referred for further investigation, and potentially treatment, by an Interventional Radiologist at a more appropriate stage earlier in the disease process.
REC name
West of Scotland REC 5
REC reference
14/WS/1032
Date of REC Opinion
26 Aug 2014
REC opinion
Favourable Opinion