Lower extremity artery disease Artery disease
Conditions
Interventions
Participants will undergo at least one, and likely multiple, NIRF measurements with ICG in addition to standard care. Measurements occur:At baseline presentation.During amputation (major or minor).Bef
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult (>18 years).Presence of foot ulcer in combination with diabetes, LEAD or both.Able to understand the information and implications of participation in the study.
Exclusion criteria
Exclusion criteria: Previous hypersensitivity or allergy to ICG, iodine or sodium iodide.Known autonomous thyroid adenoma or hyperthyroidism.Pregnancy or breastfeeding.Any condition that the investigator considers to be potentially jeopardizing the patient’s well-being or the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete wound healing within six months.Time to wound healing.Limb salvage versus major amputation.Perfusion parameters derived from NIRF imaging: Tmax, normalized ingress slope, and area under the curve. | — |
Secondary
| Measure | Time frame |
|---|---|
| Infection, re-intervention, mortality.Correlation of perfusion parameters with angiography and duplex ultrasound.Health-related quality of life (EQ-5D). | — |
Countries
Netherlands
Contacts
Public ContactL.E. Aa
Leids Universitair Medisch Centrum
Outcome results
None listed