Skip to main content
Clinical Trials/NCT06011447
NCT06011447
Completed
Not Applicable

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

The Leeds Teaching Hospitals NHS Trust1 site in 1 country8 target enrollmentApril 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Diseases
Sponsor
The Leeds Teaching Hospitals NHS Trust
Enrollment
8
Locations
1
Primary Endpoint
fail to heal wounds
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
January 1, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

fail to heal wounds

Time Frame: 7 months

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

Study Sites (1)

Loading locations...

Similar Trials