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Near infra-red imaging of the microvasculature in comparison with resin casting of amputated limbs

Near infra-red imaging of the microvasculature in comparison with resin casting of amputated limbs

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617001097336
Enrollment
6
Registered
2017-07-27
Start date
2018-09-27
Completion date
2019-08-30
Last updated
2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We hypothesise that near-infra red imaging will allow the visualization and quantification of microvenous reflux (i.e., reflux in the tiny skin vessels) which has previously been unseen using standard ultrasound technologies, and that the results of this imaging will correlate with microvenous insufficiencies seen in retrograde resin casting. This may give us further insight into understanding how venous insufficiency leads to skin damage, and in ascertaining patient risk.

Interventions

Part one, proof of concept: Two amputated lower limbs will be imaged with a near-infra red (NIR) camera and indocyanine green dye contrast. The imaging will involve recording the peak intensity of the fluorescence of the dye, and the time taken to peak intensity. Bright spots will be indicated and marked on the limb. After imaging, the limb will undergo resin casting, whereby resin will be injected into veins of the limb and allowed to set. This will produce a map of the micro venous system, wi

Part one, proof of concept: Two amputated lower limbs will be imaged with a near-infra red (NIR) camera and indocyanine green dye contrast. The imaging will involve recording the peak intensity of the fluorescence of the dye, and the time taken to peak intensity. Bright spots will be indicated and marked on the limb. After imaging, the limb will undergo resin casting, whereby resin will be injected into veins of the limb and allowed to set. This will produce a map of the micro venous system, with markers where imaging showed potential areas of reflux. The resulting resin map will be analysed to determine the degree of venous reflux in multiple regions of interest in the limb. This will be correlated with the data obtained from the NIR imaging. Part Two: Continuation If part one provides usable data from both imaging and resin casting, participants will be asked if they would like to undergo imaging prior to amputation, to allow for better correlation. The imaging session will take less than one hour, and involves cannulating the participant for a local injection of indocyanine green (ICG) dye. of ICG solution (0.02 mg/ml) will be injected into a vein in the foot or at the level of the ankle, for the duration of the imaging sequence . This may be possible in neuropathic patients, who do not feel pain in their limbs. Patients will only be included in this extra imaging if a vascular surgeon who is not part of the study deems it appropriate. We aim to have three more participants, and hope to have at least one who is able to undergo imaging prior to amputation.

Sponsors

Dunedin Public Hospital
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria: - patients awaiting an amputation of a lower limb. Inclusion criteria for undergoing NIR imaging prior to amputation: - Patient consent. - A vascular surgeon who is not an investigator in this study determines that the imaging (prior to the amputation) will not cause undue stress or pain for the patient.

Exclusion criteria

Patients who are not referred for a lower limb amputation will be excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026