Peri-revascularisation changes in Chronic Limb Threatening Ischaemia
Research type
Research Study
Full title
Peri-revascularisation Changes in Lower Limb Muscles in Patients with Peripheral Arterial Disease
IRAS ID
320685
Contact name
Sandip Nandhra
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust Newcastle Joint Research Office
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Patients with poor circulation to their legs, a condition known as peripheral arterial disease, experience a range of symptoms, from pain while walking to pain at rest and severe foot and leg tissue damage, risking limb loss and even death. The majority of these patients undergo procedures to enhance leg circulation, aiming to improve symptoms and overall quality of life.
Therefore, our objective is to investigate the impact on patients' leg muscles before and after improving their poor leg circulation, correlating these changes with improvements in walking ability and quality of life following interventions.
Currently, very little is known about leg muscle function and associated changes in structure and biology in patients with poor blood supply. This study seeks to address this gap by obtaining leg muscle biopsies from consenting patients. Subsequently, these patients will undergo circulation-improving operations (either keyhole or open surgery as routine), followed by additional leg muscle biopsies at a later date to explore any changes in leg muscle structure or biology. This process will provide insights into the types of muscle changes and how we can enhance muscle function for a better quality of life.
Patients will be identified by the clinical team in the vascular surgery outpatient clinics or inpatient wards where they will be invited to the study and consented. Study cohorts will be patients with peripheral arterial disease undergoing intervention, patients with peripheral arterial disease undergoing major lower limb amputation, and healthy volunteer who do not have peripheral arterial disease but undergoing an intervention for other reasons such as venous disease or aortic aneurysms.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/LO/0427
Date of REC Opinion
12 Jun 2024
REC opinion
Unfavourable Opinion