Evaluation of optical imaging in foot ulcer management
- Conditions
- Foot ulcersSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN50978600
- Lead Sponsor
- niversity of Surrey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
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)
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>2. Blood flow measured using photoplethysmography in feet at baseline and after angioplasty (subgroup)
- Secondary Outcome Measures
Name Time Method 1. Ankle brachial pressure index measured using ankle Doppler based estimated ABPI (eABPI) at baseline and after angioplasty (subgroup)<br>2. Toe brachial pressure index measured using arterial plethysmography with cuff at baseline and after angioplasty (subgroup)<br>3. Peripheral vascular disease in lower extremity arteries measured with duplex ultrasound at baseline and after angioplasty (subgroup)<br>4. 1-year outcome (major amputation, death, revascularisation, wound healing) measured using electronic patient records over 1 year