Critical Limb Ischemia Clinical Trial
Official title:
Exercise In Critical Limb Ischaemia Patients Having Surgery
Patients with critical limb ischaemia (CLI) are at risk of losing their limb and/or life and
therefore have no option but to undergo bypass or amputation surgery. This presents a major
physical challenge to the body and patients with low fitness will struggle to overcome the
effects of the surgical trauma. Currently there is a high risk of a poorer outcome for CLI
patients than with most other surgical procedures, as demonstrated by high rates of
complications (20-46%) and 30 day mortality (7.5-13.5%). Up to 30% of people will die within
the first year. Exercise and respiratory muscle training, before surgery, has shown a
reduction in complications in other surgical specialties.
Around 50% of CLI patients present as an emergency, meaning training before admission is not
feasible, so the Investigator proposes to see if training during the hospital stay will aid a
better recovery. However, as this has not been done in vascular surgical patients the
investigator needs to initially test if this intervention is possible in this patient group
in an acute hospital setting.The aim of this proof of concept single cohort study is to
assess whether an exercise intervention, started on hospital admission and continued
post-surgery, for the duration of the hospital admission, is safe, acceptable, well tolerated
and feasible to run in an acute ward setting.
The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle
training (POWERbreathe) and upper body strength training every second day until discharge.
The Investigator will assess safety by recording adverse events and acceptability by
adherence to exercise programme and qualitative interviews. The Investigator will evaluate
processes and completeness of data collection and describe before and after measures of
physical fitness.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
| Recruiting |
NCT03668353 -
Recombinant SeV-hFGF2/dF Injection for PAOD
|
Phase 1 | |
| Recruiting |
NCT04110964 -
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
|
Phase 1 | |
| Not yet recruiting |
NCT03994666 -
Cell Therapy in Critical Limb Ischemia
|
Phase 2 | |
| Recruiting |
NCT02389023 -
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
|
N/A | |
| Completed |
NCT02539940 -
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
|
||
| Not yet recruiting |
NCT02498080 -
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
|
N/A | |
| Recruiting |
NCT02239419 -
Evaluation of Carbothera in the Treatment of Foot Ulcers
|
N/A | |
| Recruiting |
NCT01938872 -
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
|
N/A | |
| Active, not recruiting |
NCT01211925 -
Distal Venous Arterialisation of Ischemic Limb
|
Phase 2/Phase 3 | |
| Completed |
NCT02454231 -
Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)
|
Phase 2/Phase 3 | |
| Completed |
NCT01758874 -
Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
|
Phase 2 | |
| Completed |
NCT02475200 -
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
|
||
| Recruiting |
NCT04583436 -
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
|
N/A | |
| Completed |
NCT04071782 -
Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore
|
N/A | |
| Completed |
NCT03669458 -
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
|
N/A | |
| Not yet recruiting |
NCT06007469 -
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
|
||
| Recruiting |
NCT04110327 -
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
|
||
| Completed |
NCT02260622 -
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
|
Phase 2 | |
| Recruiting |
NCT02054416 -
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
|
N/A |