Peripheral Arterial DiseaseNCT03854097
Effect of Intermittent Pressure in Patients With PAD
A study testing Active Intermittent Negative Pressure (INP) in people with Peripheral Arterial Disease, run by University of Dundee at 1 site in United Kingdom.
Trial summary
The study will evaluate the effect of intermittent negative pressure (INP) on peripheral arterial disease (PAD) patient vascular function and blood flow. Patients will be given either -40mmHg INP or -10mmHg INP which will act as a placebo. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Active Intermittent Negative Pressure (INP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2019to 5 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PAD Patients:
- Age ≥ 18 years
- Attending vascular outpatient clinics or admitted in ward with PAD.
- ABPI <0.9
- Healthy Volunteers:
- Age ≥ 18 years
- No current or previous significant cardiovascular illness
- Able to give written informed consent
Who cannot join
- PAD Patients:
- Unable to give written informed consent
- Patients with deep venous thrombosis
- Pregnant women
- Healthy Volunteers:
- Positive medical history of: Vascular diseases such as PAD, stroke, IHD, hypertension... etc.
Show all 10Show fewer
- Haematological conditions such as hypercoagulability, deep venous thrombosis... etc.,
- Alcohol excess
- Unable to give written informed consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Medicine, University of Dundee, Ninewells Hospital & Medical School
Dundee
About this study
Official title: Mechanistic Insights Into Changes in Blood Flow Following Application of Intermittent Negative Pressure
The study will evaluate the effect of intermittent negative pressure (INP) on peripheral arterial disease (PAD) patient vascular function and blood flow. Patients will be given either -40mmHg INP or -10mmHg INP which will act as a placebo. Healthy volunteers will be given -40mmHg INP to evaluate changes in vascular function and blood flow with INP in healthy physiology.
Read the detailed description
Atherosclerosis occurs when blood supply to the lower limbs is restricted upon accumulation of fat in the arteries. Atheroslerosis in the lower limbs is termed peripheral arterial disease (PAD). The initial symptom is pain in the lower limbs followed by ulceration and gangrene. The literature has indicated that intermittent negative pressure (INP) can be used to reduce pain and facilitate wound healing. INP is a non-invasive technique that aims to increase arterial and skin blood flow in lower limbs and foot. This study aims to investigate the underlying mechanisms that are involved in changes in blood flow following application of INP. The Flow-Ox 'boot' will be used to apply INP for periods ranging from 4-8 weeks, for an hour twice per day, to the lower limb to determine the effects of INP on vascular function and blood flow. Specifically, vascular tests such as assessments of endothelial function, arterial stiffness, ankle-brachial pressure index (ABPI) and blood borne metabolic and inflammatory markers will be performed before and after INP application. A pain chart will be employed before and after INP application to determine whether there is any change in perception of pain felt by individuals who suffer from pain associated with lower limb arterial disease.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Active Intermittent Negative Pressure (INP), Placebo Intermittent Negative Pressure (INP)
- Keywords
- PAD
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Intermittent Negative Pressure (INP)Device
Application of -40mmHg negative pressure on the lower limb
Placebo Intermittent Negative Pressure (INP)Device
Application of -10mmHg negative pressure on the lower limb
| Study group | Role | What they receive |
|---|---|---|
| Active PAD group | Experimental | -40mmHg of Intermittent Negative Pressure (INP) for 4-8 weeks. Receives: Device: Active Intermittent Negative Pressure (INP) |
| Placebo PAD group | Experimental | -10mmHg of Intermittent Negative Pressure (INP) for 4-8 weeks. Receives: Device: Placebo Intermittent Negative Pressure (INP) |
| Healthy Volunteers | Experimental | -40 mmHg of Intermittent Negative Pressure (INP) for 5 days Receives: Device: Active Intermittent Negative Pressure (INP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microvascular blood flow
Microvascular blood flow measurement in foot using laser Dopper imaging.
Measured: Baseline, 1 day and 4-8 weeks
Change in microvascular endothelial function
Peak blood perfusion response to acetylcholine (ACh) delivered by iontophoresis will be measured using a laser Doppler imager.
Measured: Baseline, 1 day and 4-8 weeks
Change in arterial stiffness
Brachial pulse wave analysis (PWA) augmentation index (Ax) and carotid-femoral pulse wave velocity (m/s) (PWV) as an indication of arterial stiffness.
Measured: Baseline, 1 day and 4-8 weeks
Change in macrovascular endothelial function
Brachial endothelial function measured as change in brachial blood vessel diameter (%) upon shear stress.
Measured: Baseline, 1 day and 4-8 weeks
Secondary outcomes (3)
Change in pain score
Self-scoring of pain felt by patient on a visual analogue scale with 0 being no pain at all to 10 being the worst pain ever felt.
Measured: Baseline, 1 day and 4-8 weeks
Change in concentration of blood borne inflammatory and oxidative stress biomarkers
Concentration of inflammatory and oxidative stress markers of endothelial activation/damage (including IL-1a, IL-6, IL-10, TNF-a, CRP, E-selectin and sICAM-1) measured in serum and plasma collected from patient blood samples.
Measured: Baseline, 1 day and 4-8 weeks
Change in Ankle-Brachial Pressure Index (ABPI)
Brachial systolic pressure and ankle (dorsalis pedis) systolic pressure (mmHg) measured using Doppler probe. ABPI calculated as ankle systolic pressure divided by brachial systolic pressure.
ABPI <0.9 = PAD, ABPI =>1.0 Normal.
Measured: Baseline, 1 day and 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start16 Feb 2019
- Primary completion5 Jun 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jody McIntosh, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854097
- Sponsor's protocol ID
- 1-014-18
- Status last verified
- Aug 2021
- First submitted
- 19 Feb 2019
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Insights Into Changes in Blood Flow Following Application of Intermittent Negative Pressure
- ClinicalTrials.gov ID
- NCT03854097
- Acronym / sponsor ID
- 1-014-18
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- 16 Feb 2019 (actual)
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate the effect of intermittent negative pressure (INP) on peripheral arterial disease (PAD) patient vascular function and blood flow. Patients will be given either -40mmHg INP or -10mmHg INP which will act as a placebo. Healthy volunteers will be given -40mmHg INP to evaluate changes in vascular function and blood flow with INP in healthy physiology.
Detailed description
Atherosclerosis occurs when blood supply to the lower limbs is restricted upon accumulation of fat in the arteries. Atheroslerosis in the lower limbs is termed peripheral arterial disease (PAD). The initial symptom is pain in the lower limbs followed by ulceration and gangrene. The literature has indicated that intermittent negative pressure (INP) can be used to reduce pain and facilitate wound healing. INP is a non-invasive technique that aims to increase arterial and skin blood flow in lower limbs and foot. This study aims to investigate the underlying mechanisms that are involved in changes in blood flow following application of INP. The Flow-Ox 'boot' will be used to apply INP for periods ranging from 4-8 weeks, for an hour twice per day, to the lower limb to determine the effects of INP on vascular function and blood flow. Specifically, vascular tests such as assessments of endothelial function, arterial stiffness, ankle-brachial pressure index (ABPI) and blood borne metabolic and inflammatory markers will be performed before and after INP application. A pain chart will be employed before and after INP application to determine whether there is any change in perception of pain felt by individuals who suffer from pain associated with lower limb arterial disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active PAD group | Experimental | Device: Active Intermittent Negative Pressure (INP)-40mmHg of Intermittent Negative Pressure (INP) for 4-8 weeks. |
| Placebo PAD group | Experimental | Device: Placebo Intermittent Negative Pressure (INP)-10mmHg of Intermittent Negative Pressure (INP) for 4-8 weeks. |
| Healthy Volunteers | Experimental | Device: Active Intermittent Negative Pressure (INP)-40 mmHg of Intermittent Negative Pressure (INP) for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Attending vascular outpatient clinics or admitted in ward with PAD.
- ABPI <0.9
- Age ≥ 18 years
- No current or previous significant cardiovascular illness
Key exclusion criteria (10 listed)
- Unable to give written informed consent
- Patients with deep venous thrombosis
- Pregnant women
- Positive medical history of: Vascular diseases such as PAD, stroke, IHD, hypertension... etc.
- Haematological conditions such as hypercoagulability, deep venous thrombosis... etc.,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Intermittent Negative Pressure (INP)Application of -40mmHg negative pressure on the lower limb | Device | Active PAD group, Healthy Volunteers |
| Placebo Intermittent Negative Pressure (INP)Application of -10mmHg negative pressure on the lower limb | Device | Placebo PAD group |
Primary outcome
Change in microvascular blood flow
Time frame: Baseline, 1 day and 4-8 weeks
Microvascular blood flow measurement in foot using laser Dopper imaging.
Change in microvascular endothelial function
Time frame: Baseline, 1 day and 4-8 weeks
Peak blood perfusion response to acetylcholine (ACh) delivered by iontophoresis will be measured using a laser Doppler imager.
Change in arterial stiffness
Time frame: Baseline, 1 day and 4-8 weeks
Brachial pulse wave analysis (PWA) augmentation index (Ax) and carotid-femoral pulse wave velocity (m/s) (PWV) as an indication of arterial stiffness.
Change in macrovascular endothelial function
Time frame: Baseline, 1 day and 4-8 weeks
Brachial endothelial function measured as change in brachial blood vessel diameter (%) upon shear stress.
3 secondary outcomes
Change in pain score
Time frame: Baseline, 1 day and 4-8 weeks
Change in concentration of blood borne inflammatory and oxidative stress biomarkers
Time frame: Baseline, 1 day and 4-8 weeks
Change in Ankle-Brachial Pressure Index (ABPI)
Time frame: Baseline, 1 day and 4-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jody McIntosh principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intermittent Negative Pressure (INP) in people with Peripheral Arterial Disease, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microvascular blood flow (time frame: Baseline, 1 day and 4-8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.