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| ID | Type | Description | Link |
|---|---|---|---|
| 14HH2054 | Other Identifier | Imperial College JRCO |
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Member of staff moved on to training post. Trial halted and terminated
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The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Best medical therapy | Active Comparator | Claudicants treated according to local protocol - no added treatment |
|
| Best medical therapy plus NMES | Experimental | In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral NMES legs | Device | Stimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute walking distance | Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15% | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Claudication distance | Treadmill test (as per absolute walking distance) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AH Davies | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital | London | United Kingdom |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 30, 2023 | |
| Reset | Jan 5, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2023 | Jan 5, 2024 |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Best medical therapy | Other | Treated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise. |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |