Laser Speckle Imaging in Ischaemic Tissue Loss

Vascular Diseases Clinical Trial

Official title:

The Use of Laser Speckle Imaging in the Evaluation of Successful Revascularisation of Patients With Ischemic Tissue Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06011447
• Other study ID #: VS20/130302
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: August 2023
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Peripheral arterial disease is a condition in which the arteries become narrowed due to a build up of cholesterol, as a result, blood cannot flow efficiently through the arteries and this can compromise the parts of the body supplied by these arteries. In its most severe form, peripheral arterial disease can lead to decomposition of tissues in the feet, leading to ulcers or gangrene. Patients with peripheral arterial disease undergo procedures to improve blood flow.

However, there are often multiple arteries to treat and each intervention carries risk. It therefore can be difficult to judge how much treatment is sufficient to promote healing. Laser Speckle Imaging is a technique used to demonstrate blood flow in the skin. It is hoped that changes in skin blood flow, as measured by LSI, immediately after a procedure to improve blood flow, may help in the decision making as to whether further intervention is necessary. An LSI scan will be performed before a procedure for tissue loss and immediately after it is performed. The patient's clinical records will then be checked to see whether the wound has improved and whether the difference in LSI scans correlated with this.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Patients with diabetes Patients with a foot ulcer or open wound Patients aged over 18 Patients able to given consent Patients undergoing femoropopliteal bypass or superficial femoral / popliteal artery angioplasty

Exclusion Criteria:

nability to consent Planned major limb amputation for the affected limb

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Other:
• Device to view the skin
Application of device to help view the wound area better

Locations

Country	Name	City	State
United Kingdom	Leeds NHS Teaching Hospitals	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fail to heal wounds	The study aims to assess whether wounds which fail to heal are associated with small differences in LSI blood flow measurements.	7 months