Laser Speckle Imaging in Ischaemic Tissue Loss

NCT06011447 | Completed

• 1 other identifier: VS20/130302
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients with diabetes and wound ulcers

Other: Device to view the skin

Interventions

Device to view the skin OTHER

Application of device to help view the wound area better

Patients with diabetes and wound ulcers

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with vascular ulcers

You may qualify if:

• 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

You may not qualify if:

• nability to consent Planned major limb amputation for the affected limb

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds NHS Teaching Hospitals

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: April 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

GB (1)