Laser Speckle Imaging in Ischaemic Tissue Loss

Completed

• Conditions: Vascular Diseases
• Interventions: Other: Device to view the skin

• Registration Number: NCT06011447
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Last Update Submitted: 2023-08-21
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with diabetes and wound ulcers	Device to view the skin	-

Primary Outcome Measures

Name	Time	Method
fail to heal wounds	7 months	The study aims to assess whether wounds which fail to heal are associated with small differences in LSI blood flow measurements.

Trial Locations

Locations (1)

Leeds NHS Teaching Hospitals; 🇬🇧 Leeds, United Kingdom