An interventional study of NMES in Intermittent Claudication and Peripheral Vascular Diseases, sponsored by Imperial College London. Completed at 11 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Imperial College London · Not applicable, Interventional, and Supportive care
Intermittent claudication (IC) is caused by a blockage in the artery of the leg, causing muscle pain. Although some evidence of the efficacy of neuromuscular electrical stimulation (NMES) in the management of patients with IC exists, further high quality research is required. This proposed study is vital to identify the contribution of clinical change using NMES, compared to the current gold standard recommended practice of supervised exercise therapy (SET) and, actual standard of care offered in the majority of the UK and Ireland, including best medical therapy (BMT). The device is expected to increase the walking distance in patients with intermittent claudication (IC), and therefore have a benefit on the same when provided in addition to supervised exercise programmes. It is also expected to cause a reduction in pain symptoms and reduced likelihood of major intervention in late stage peripheral arterial disease (PAD). The principal research objective is to assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device as an adjunct to the local standard care that is available at the study randomisation sites, in order to improve walking distance in patients with intermittent claudication (IC).
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's enrollment of 200 is above the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There will be no change to the local site standard of care for patients with IC attributed to participation in this trial. Those sites with Supervised Exercise Therapy (SET) will continue to provide this intervention as per their normal standard of care and locally agreed protocol.
Local therapy + Neuromuscular Electrical Stimulation (NMES)
Device: NMES
NMES device to be used for up to 3 hours daily in 30 minute sessions for 3 months.
Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups
Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months
Time frame: 3 months
Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups
Measured by treadmill testing. ICD in meters at baseline and 3 months
Time frame: 3 months
Quality of Life - Intermittent Claudication Questionnaire (ICQ)
Patient questionnaire. Used to assess change in disease-specific QoL.
Time frame: Baseline, 3 months, 6 months, 12 months
Quality of Life - EuroQoL 5D (EQ5D) Health Scale
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Time frame: Baseline, 3 month, 6 month and 12 months
Quality of Life Short Form 36 (SF-36) Physical Component Summary
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Time frame: Baseline, 3 month, 6 month and 12 months
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months
Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include volume flow (VF, cc/min) to assess whether using the device increases this measurement.
Time frame: 3 months
Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline and 12 Months
The single fibre laser optical probe of the LDF machine will be positioned on the dorsal aspect of the foot using single use adhesive pads. Flux, as a measure of superficial skin blood flow will be measured to assess whether using the device increases this measurement.
Time frame: Baseline, 3 month, 6 month and 12 months
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline and 12 Months
The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.
Time frame: Baseline, 3 month, 6 month and 12 months
Health Economic Assessment
The economic analyses will compare local therapy (supervised exercise therapy (SET) or exercise advice (EA) only) versus the intervention (local therapy + Neuromuscular Electrical Stimulation, NMES) in patients with Intermittent Claudication. The analyses will be based on a (i) patient level in-trial cost-effectiveness analysis, (ii) a decision model and (iii) budget impact assessment. The in-trial analysis will calculate quality-adjusted life years (QALYs) over the one year time horizon of the trial.
Time frame: Baseline, 3 month, 6 month and 12 months
Compliance With Interventions - Exercise Advice (EA)
Comparison of compliance with exercise advice as per local standard of care.
Time frame: 3 months
Device Experience Questionnaire - Ease of Use
To report ease of device use and suggest any developments.
Time frame: 3 months
Quality of Life - EuroQoL 5D (EQ5D) Health Index
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Time frame: Baseline, 3 months, 6 months, 12 months
Quality of Life Short Form 36 (SF-36) Mental Component Summary
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
Time frame: Baseline, 3 months, 6 months, 12 months
Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 3 Months
Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include time-averaged mean volume (TAMV, cm/s) to assess whether using the device increases this measurement.
Time frame: 3 months
Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline and 12 Months
The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.
Time frame: Baseline, 3 months, 6 months and 12 months
Compliance With Interventions - Supervised Exercise Therapy (SET)
Comparison of compliance with SET classes.
Time frame: 3 months
Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES)
Compliance with NMES device. NMES compliance data collected from the data logger fitted to device and patient diary will be combined to report overall compliance.
Time frame: 3 months
Device Experience Questionnaire - Reduces Leg Pain
To report ease of device use and suggest any developments.
Time frame: 3 months
Device Experience Questionnaire - Increased Walk Distance
To report ease of device use and suggest any developments.
Time frame: 3 months
Device Experience Questionnaire - Used as Instructed
To report ease of device use and suggest any developments.
Time frame: 3 months
Device Experience Questionnaire - Could Have Used More
To report ease of device use and suggest any developments.
Time frame: 3 months
Device Experience Questionnaire - Used After Treatment
To report ease of device use and suggest any developments.
Time frame: 3 months
Sub-group Analysis 1 - Difference in Absolute Walking Difference Between Baseline and 3 Months SET Sites vs Non-SET Sites
Subgroup analysis 1: Right censored Tobit regression model for AWD at 3 months to assess the effects SET sites vs non-SET sites (NMES+SET+BMT \& SET+BMT vs NMES+BMT \& BMT).
Time frame: 3 months
Sub-group Analysis 2 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs SET+BMT)
Subgroup analysis 2: Right censored Tobit Regression model for AWD at 3 months to assess the effects of NMES in the SET sites (NMES+SET+BMT vs SET+BMT).
Time frame: 3 months
Sub-group Analysis 3 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs BMT)
Subgroup analysis 3: Right censored Tobit regression model for the AWD at 3 months to assess the effects of NMES in the non-SET sites (NMES+BMT vs BMT).
Time frame: 3 months
Sub-group Analysis 4 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs. SET+BMT)
Subgroup analysis 4: Right censored Tobit regression model for AWD at 3 months to assess the effects of (NMES+BMT) has a similar effect as (SET+BMT).
Time frame: 3 months
Sub-group Analysis 5 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs. NMES+BMT)
Subgroup analysis 5: Determine if (NMES+SET+BMT) is more effective than (NMES+BMT).
Time frame: 3 months
| Milestone | Control | Device |
|---|---|---|
| Started | 102 | 98 |
| Completed | 78 | 80 |
| Not completed | 24 | 18 |
Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months
| Meters | Control | Device |
|---|---|---|
| Baseline | 220.12 ± 148.27 | 242.97 ± 187.08 |
| 3 months | 327.74 ± 222.65 | 370.38 ± 251.38 |
Measured by treadmill testing. ICD in meters at baseline and 3 months
| Meters | Control | Device |
|---|---|---|
| Baseline | 99.10 ± 77.06 | 105.79 ± 106.27 |
| 3 months | 179.73 ± 147.03 | 211.45 ± 181.83 |
Patient questionnaire. Used to assess change in disease-specific QoL.
| score on a scale | Control | Device |
|---|---|---|
| Baseline | 45.92 ± 13.09 | 41.98 ± 13.26 |
| 3 months | 41.33 ± 14.52 | 36.55 ± 13.86 |
| 6 months | 39.27 ± 14.51 | 35.20 ± 15.07 |
| 12 months | 36.21 ± 16.45 | 36.99 ± 17.38 |
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
| score on a scale | Control | Device |
|---|---|---|
| Baseline | 45.92 ± 13.09 | 41.98 ± 13.26 |
| 3 months | 41.33 ± 14.52 | 36.55 ± 13.86 |
| 6 months | 39.27 ± 14.51 | 35.20 ± 15.07 |
| 12 months | 36.21 ± 16.45 | 36.99 ± 17.38 |
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
| score on a scale | Control | Device |
|---|---|---|
| Baseline | 36.14 ± 7.90 | 35.71 ± 8.22 |
| 3 months | 37.42 ± 8.48 | 38.80 ± 8.87 |
| 6 months | 37.62 ± 9.85 | 39.47 ± 9.74 |
| 12 months | 39.46 ± 9.40 | 38.16 ± 9.98 |
Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include volume flow (VF, cc/min) to assess whether using the device increases this measurement.
| cc/min | Control | Device |
|---|---|---|
| Baseline | 296.89 ± 198.40 | 300.06 ± 155.10 |
| 3 months | 280.96 ± 179.03 | 296.77 ± 146.30 |
The single fibre laser optical probe of the LDF machine will be positioned on the dorsal aspect of the foot using single use adhesive pads. Flux, as a measure of superficial skin blood flow will be measured to assess whether using the device increases this measurement.
| Unitless | Treatment | Control |
|---|---|---|
| Baseline | 2.61 ± 0.58 | 2.38 ± 0.56 |
| 3 months | 2.79 ± 0.69 | 2.30 ± 0.65 |
| 6 months | 2.49 ± 0.57 | 2.50 ± 0.62 |
| 12 months | 2.64 ± 0.61 | 2.53 ± 0.56 |
The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.
| Ratio | Control | Device |
|---|---|---|
| Baseline | 0.76 ± 0.21 | 0.72 ± 0.18 |
| 3 months | 0.74 ± 0.23 | 0.72 ± 0.21 |
| 6 months | 0.77 ± 0.22 | 0.74 ± 0.2 |
| 12 months | 0.79 ± 0.23 | 0.74 ± 0.22 |
The economic analyses will compare local therapy (supervised exercise therapy (SET) or exercise advice (EA) only) versus the intervention (local therapy + Neuromuscular Electrical Stimulation, NMES) in patients with Intermittent Claudication. The analyses will be based on a (i) patient level in-trial cost-effectiveness analysis, (ii) a decision model and (iii) budget impact assessment. The in-trial analysis will calculate quality-adjusted life years (QALYs) over the one year time horizon of the trial.
| QALY | Treatment | Control |
|---|---|---|
| Health Economic Assessment | 0.6459 (0.6032 to 0.6886) | 0.6355 (0.5992 to 0.6718) |
Comparison of compliance with exercise advice as per local standard of care.
| Participants | Compliance to Exercise Advice |
|---|---|
| Complier | 99 |
| Non-complier | 52 |
| Missing | 39 |
To report ease of device use and suggest any developments.
| Participants | Device Arm |
|---|---|
| 1 Very easy | 77 |
| 2 | 6 |
| 3 | 1 |
| 4 | 0 |
| 5 Very difficult | 0 |
| Missing | 4 |
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
| score on a scale | Control | Device |
|---|---|---|
| Baseline | 69.61 ± 17.69 | 69.73 ± 18.03 |
| 3 months | 66.11 ± 21.09 | 74.02 ± 15.13 |
| 6 months | 68.36 ± 20.85 | 73.13 ± 19.32 |
| 12 months | 68.03 ± 19.61 | 70.40 ± 20.98 |
Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.
| score on a scale | Control | Device |
|---|---|---|
| Baseline | 49.75 ± 12.47 | 52.06 ± 11.61 |
| 3 months | 48.24 ± 13.15 | 52.99 ± 10.05 |
| 6 months | 49.09 ± 10.90 | 52.79 ± 10.73 |
| 12 months | 48.90 ± 12.24 | 52.62 ± 11.68 |
Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include time-averaged mean volume (TAMV, cm/s) to assess whether using the device increases this measurement.
| cm/s | Control | Device |
|---|---|---|
| Baseline | 11.28 ± 5.64 | 12.23 ± 6.47 |
| 3 months | 11.78 ± 5.77 | 12.47 ± 5.39 |
The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.
| Ratio | Control | Device |
|---|---|---|
| Baseline | 0.77 ± 0.22 | 0.76 ± 0.21 |
| 3 months | 0.78 ± 0.22 | 0.77 ± 0.21 |
| 6 months | 0.80 ± 0.28 | 0.76 ± 0.23 |
| 12 months | 0.79 ± 0.23 | 0.78 ± 0.21 |
Comparison of compliance with SET classes.
| Participants | Compliance to Supervised Exercise Therapy (SET) |
|---|---|
| Complier | 69 |
| Non-complier | 19 |
| Missing | 11 |
Compliance with NMES device. NMES compliance data collected from the data logger fitted to device and patient diary will be combined to report overall compliance.
| Participants | Compliance to Neuromuscular Electrical Stimulation (NMES) |
|---|---|
| Complier | 68 |
| Non-complier | 12 |
| Missing | 12 |
To report ease of device use and suggest any developments.
| Participants | Device Arm |
|---|---|
| 1-Yes, a lot | 14 |
| 2 | 22 |
| 3 | 26 |
| 4 | 11 |
| 5-Not at all | 11 |
| Missing | 4 |
To report ease of device use and suggest any developments.
| Participants | Device Arm |
|---|---|
| No | 8 |
| No change | 19 |
| Yes | 57 |
| Missing | 4 |
To report ease of device use and suggest any developments.
| Participants | Device Arm |
|---|---|
| No | 2 |
| Yes | 82 |
| Missing | 4 |
To report ease of device use and suggest any developments.
| Participants | Device Arm |
|---|---|
| No | 28 |
| Yes | 56 |
| Missing | 4 |
To report ease of device use and suggest any developments.
| Participants | Device Arm |
|---|---|
| 1-Yes, a lot | 51 |
| 2 | 13 |
| 3 | 16 |
| 4 | 0 |
| 5-Not at all | 4 |
| Missing | 4 |
Subgroup analysis 1: Right censored Tobit regression model for AWD at 3 months to assess the effects SET sites vs non-SET sites (NMES+SET+BMT \& SET+BMT vs NMES+BMT \& BMT).
| Units | Treatment Effect in SET Sites vs Non-SET Sites |
|---|---|
| Sub-group Analysis 1 - Difference in Absolute Walking Difference Between Baseline and 3 Months SET Sites vs Non-SET Sites | 3.205 (1.689 to 4.720) |
Subgroup analysis 2: Right censored Tobit Regression model for AWD at 3 months to assess the effects of NMES in the SET sites (NMES+SET+BMT vs SET+BMT).
| Units | Treatment Effect of NMES in the SET Sites |
|---|---|
| Sub-group Analysis 2 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs SET+BMT) | 1.724 (-0.560 to 4.008) |
Subgroup analysis 3: Right censored Tobit regression model for the AWD at 3 months to assess the effects of NMES in the non-SET sites (NMES+BMT vs BMT).
| Units | Treatment Effect of NMES in the Non-SET Sites |
|---|---|
| Sub-group Analysis 3 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs BMT) | -0.090 (-2.014 to 1.833) |
Subgroup analysis 4: Right censored Tobit regression model for AWD at 3 months to assess the effects of (NMES+BMT) has a similar effect as (SET+BMT).
| Units | Investigate if the Treatment Effect of (NMES+BMT) Has a Similar Effect as (SET+BMT) |
|---|---|
| Sub-group Analysis 4 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs. SET+BMT) | -2.419 (-4.324 to -0.513) |
Subgroup analysis 5: Determine if (NMES+SET+BMT) is more effective than (NMES+BMT).
| Units | Determine if (NMES+SET+BMT) is More Effective Than (NMES+BMT) |
|---|---|
| Sub-group Analysis 5 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs. NMES+BMT) | 4.248 (2.229 to 6.268) |
Subgroup analysis 6: Determine if (BMT) is more effective than (NMES+SET+BMT).
| Units | Determine if (BMT) is More Effective Than (NMES+SET+BMT) |
|---|---|
| Sub-group Analysis 6 - Difference in Absolute Walking Difference Between Baseline and 3 Months (BMT vs. NMES+SET+BMT) | -4.098 (-6.560 to -1.636) |
Subgroup analysis 7: Determine if (BMT) is more effective than (BMT+SET). The sample size in this group is N=80 (n=31 in BMT and n=49 in BMT+SET).
| Units | Determine if (BMT) is More Effective Than (BMT+SET) |
|---|---|
| Sub-group Analysis 7 - Difference in Absolute Walking Difference Between Baseline and 3 Months (BMT vs. BMT+SET) | 2.341 (0.054 to 4.629) |
Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a short distance at baseline in the ITT population (N=40). The AWD at baseline was divided into three strati: Short, Medium and Long distances (set at \<25%, 25%-75% and \>75% respectively) using the descriptive statistics - short distance defined as \<100m.
| Units | Treatment Versus Control: Primary Outcome for Patients Who Walked a Short Distance at Baseline |
|---|---|
| Post-hoc: Difference in Absolute Walking Difference for Patients Who Walked a Short Distance at Baseline (Baseline to 3 Months) | 0.426 (-3.499 to 4.351) |
Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a medium distance at baseline in the ITT population (N=80). The AWD at baseline was divided into three strati: Short, Medium and Long distances (set at \<25%, 25%-75% and \>75% respectively) using the descriptive statistics - medium distance defined as between 100m and 340m.
| Units | Treatment Versus Control: Primary Outcome for Patients Who Walked a Medium Distance at Baseline |
|---|---|
| Post-hoc: Difference in Absolute Walking Difference for Patients Who Walked a Medium Distance at Baseline (Baseline to 3 Months) | 0.215 (-1.805 to 2.235) |
Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a long distance at baseline in the ITT population (N=40). The AWD at baseline was divided into three strati: Short, Medium and Long distances (set at \<25%, 25%-75% and \>75% respectively) using the descriptive statistics - long distance defined as \>340m.
| Units | Treatment Versus Control: Primary Outcome for Patients Who Walked a Long Distance at Baseline |
|---|---|
| Post-hoc: Difference in Absolute Walking Difference for Patients Who Walked a Long Distance at Baseline (Baseline to 3 Months) | 2.877 (0.506 to 5.248) |
Collected over Adverse event data was collected during the full study duration (12 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 2/102 (2%) | 13/102 (12.7%) | 44/102 (43.1%) |
| Device | 2/98 (2%) | 11/98 (11.2%) | 47/98 (48%) |
| Event | Control | Device |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/102 | 2/98 |
| Abdominal painGastrointestinal disorders | 0/102 | 2/98 |
| Peripheral arterial occlusive diseaseVascular disorders | 1/102 | 1/98 |
| Acute myocardial infarctionCardiac disorders | 0/102 | 1/98 |
| Cardiac failure acuteCardiac disorders | 0/102 | 1/98 |
| Chest painCardiac disorders | 1/102 | 1/98 |
| Groin abscessInfections and infestations | 0/102 | 1/98 |
| Peripheral endarterectomySurgical and medical procedures | 0/102 | 1/98 |
| UrosepsisInfections and infestations | 0/102 | 1/98 |
| vomitingGastrointestinal disorders | 1/102 | 1/98 |
| Event | Control | Device |
|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 4/102 | 6/98 |
| Lower respiratory tract infectionInfections and infestations | 5/102 | 4/98 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/102 | 4/98 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 4/102 | 1/98 |
| AnaemiaBlood and lymphatic system disorders | 0/102 | 3/98 |
| GoutMetabolism and nutrition disorders | 0/102 | 3/98 |
| HypertensionVascular disorders | 1/102 | 3/98 |
| Urinary Tract InfectionInfections and infestations | 3/102 | 0/98 |
| Atrial fibrillationCardiac disorders | 0/102 | 2/98 |
| Peripheral swellingGeneral disorders | 0/102 | 2/98 |
Baseline analysis including all patents randomised minus those removed post-randomisation due to screen failures.
| Age, Continuous(years) | Control | Device | Total |
|---|---|---|---|
| Mean | 67.44 ± 9.44 | 68.17 ± 8.84 | 67.79 ± 9.13 |
| Sex: Female, Male(Participants) | Control | Device | Total |
|---|---|---|---|
| Female | 28 | 22 | 50 |
| Male | 70 | 70 | 140 |
| Race (NIH/OMB)(Participants) | Control | Device | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 3 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 90 | 87 | 177 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Body Mass Index(kg/m^2) | Control | Device | Total |
|---|---|---|---|
| Mean | 28.63 ± 6.66 | 28.10 ± 5.12 | 28.37 ± 5.95 |
| Smoking status(participants) | Control | Device | Total |
|---|---|---|---|
| Current smoker | 34 | 22 | 56 |
| Former smoker | 58 | 64 | 122 |
| Never | 6 | 6 | 12 |
| Medical history(participants) | Control | Device | Total |
|---|---|---|---|
| Hypertension | 63 | 65 | 128 |
| Stroke | 9 | 9 | 18 |
| Heart attack | 17 | 15 | 32 |
| High cholesterol | 64 | 68 | 132 |
| Angina | 13 | 10 | 23 |
| Diabetes | 26 | 21 | 47 |
| Bypass revascularisation | 12 | 5 | 17 |
| Angio revascularisation | 25 | 14 | 39 |
| Medication(participants) | Control | Device | Total |
|---|---|---|---|
| Antiplatelets | 79 | 75 | 154 |
| Lipid modification therapy | 81 | 80 | 161 |
| Anticoagulant | 15 | 10 | 25 |
| Antihypertensives | 65 | 66 | 131 |
| Retired(participants) | Control | Device | Total |
|---|---|---|---|
| Yes | 69 | 68 | 137 |
| No | 29 | 24 | 53 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Mar 2021, 37 months.
Results were first posted in Apr 2024, 3 years after primary completion.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's 37 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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