Evaluation of optoacoustic imaging in patients with foot ulcers
Research type
Research Study
Full title
Evaluation of optoacoustic imaging in patients with foot ulcers: A cross-sectional pilot study
IRAS ID
331195
Contact name
Christian Heiss
Contact email
Sponsor organisation
University of Surrey
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Background: Non-healing foot wounds (ulcers) are frequent and lead to poor quality-of-life with high risk of amputation and mortality. A major reason for wounds not to heal are blocked arteries in the legs. Currently, the standard test to measure the blood flow in the legs is called ankle brachial pressure index (ABPI) and it requires blood pressure measurement with a cuff at the ankle. However, ABPI is not frequently performed, may miss diagnoses, and does not measure blood flow in the foot where ulcers are.
Optoacoustic imaging (OAI) and photoplethysmography (PPG) are 2 new non-invasive methods that can use light to measure oxygen and blood flow through the skin, but these have not been tested in patients with ulcers.
Aim: The aim of the study is to evaluate the value of OAI and PPG in patients with foot ulcers.
Hypothesis: OAI and PPG can provide additional important clinical information otherwise not available.
Objectives: (a) Assess OAI and PPG in tissue close to non-healing wounds and compare this with standard-of-care investigations; (b) Test if OAI and PPG can detect improvements in blood flow after ‘un-blocking of arteries’ with surgery; (c) Explore if the results of OAI and PPG can predict the 1-year outcomes better than standard investigations.
Study design: 40 patients with ulcers will be prospectively recruited in the multidisciplinary diabetic foot and vascular clinics. OAI and PPG scans will be performed at several sites along the leg and foot in addition to standard investigations (ultrasound, ABPI, toe pressure) and baseline medical and sociodemographic characteristics. Some patients will undergo surgery to improve blood flow as part of usual care. In these patients, we will repeat all measurements after surgery. We will collect 1 year outcome data (wound healing, amputation, mortality) based on electronic patient records.REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0242
Date of REC Opinion
10 Jul 2024
REC opinion
Favourable Opinion