Laser Speckle Imaging in Ischaemic Tissue Loss

Sponsor

The Leeds Teaching Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT06011447

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Diseases	Other: Device to view the skin

Study Design

Study Type:

Observational

Actual Enrollment :

8 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients with diabetes and wound ulcers	Other: Device to view the skin Application of device to help view the wound area better

Arm

Intervention/Treatment

Patients with diabetes and wound ulcers

Other: Device to view the skin

Application of device to help view the wound area better

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds NHS Teaching Hospitals	Leeds		United Kingdom

Sponsors and Collaborators

The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Leeds Teaching Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT06011447

Other Study ID Numbers:

VS20/130302

First Posted:

Aug 25, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Aug 25, 2023