Foot ulcers Skin and Connective Tissue Diseases
Conditions
Interventions
Patients with ulcers will be prospectively recruited in the multidisciplinary diabetic foot and vascular clinics. Optoacoustic imaging (OAI) and photoplethysmography (PPG) scans will be performed at s
Sponsors
University of Surrey
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years or greater 2. Non-healing foot wound for at least 4 weeks despite wound care 3. Scheduled for/referred to routine vascular assessment, multidisciplinary foot team clinic or endovascular revascularisation 4. Willing and able to provide informed consent 5. Vascular ultrasound exam required including Ankle Brachial Pressure Index (ABPI) and Toe Brachial Index (TBI)
Exclusion criteria
Exclusion criteria: 1. Heart failure New York Heart Association (NYHA) =3 2. Systemic inflammation 3. Critically ill, American Society of Anesthesiologists (ASA) IV 4. Extensive foot wounds making OAI scanning impossible 5. No toes to measure TBI 6. Leg wounds or skin conditions preventing ABPI, OAI or ultrasound investigations 7. Participants who are unable to wear the laser safety goggles 8. Tattoos in the field of view for OAI scanner 9. Currently under phototherapy 10. History of photosensitising disease (e.g. porphyria, Lupus erythematosus) 11. Experiencing photo-toxicity associated with currently taking or having taken photosensitizing agents within the previous 72 h (e.g. sulfonamides, ampicillin, tetracycline, doxycycline) 12. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tissue oxygenation and blood flow measured using optoacoustic imaging in feet at baseline (all) and after angioplasty (subgroup that receives angioplasty as standard of care) 2. Blood flow measured using photoplethysmography in feet at baseline and after angioplasty (subgroup) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ankle brachial pressure index measured using ankle Doppler based estimated ABPI (eABPI) at baseline and after angioplasty (subgroup) 2. Toe brachial pressure index measured using arterial plethysmography with cuff at baseline and after angioplasty (subgroup) 3. Peripheral vascular disease in lower extremity arteries measured with duplex ultrasound at baseline and after angioplasty (subgroup) 4. 1-year outcome (major amputation, death, revascularisation, wound healing) measured using electronic patient records over 1 year | — |
Countries
England, United Kingdom
Contacts
Public ContactChristian Heiss
Outcome results
None listed