Peripheral Arterial DiseaseNCT04830254
Correlation Between Selected Haematological and Doppler Ultrasonic Parameters in Peripheral Arterial Diseased Patients
A study testing Transcutaneous Electrical Nerve Stimulation(TENS) device in people with Peripheral Arterial Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation(TENS) device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2021to 20 May 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral Leriche-Fontaine stage-II PAD
- Both sexes
- Aged 50 to 60 years
- Outpatients
- Clinically stable
- Sedentary
- Not participating in any physical activity last 3 months
Who cannot join
- Walking disorders related to orthopedic or neuromuscular disease
- Renal insufficiency requiring dialysis (Renal diseases)
- Known and documented myopathy
- Progressive cancer
- Associated progressive disease causing a deterioration in general health
- Participation in another research protocol
Show all 9Show fewer
- Skin disorder making it impossible to use TENS
- Absolute contraindication to physical activity
- Presence of a pacemaker/defibrillator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients
Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.
Read the detailed description
The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Transcutaneous Electrical Nerve Stimulation(TENS) device
- 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.
Transcutaneous Electrical Nerve Stimulation(TENS) deviceDevice
Also called TENS
The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| study group(A) | Active comparator | Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks. Receives: Device: Transcutaneous Electrical Nerve Stimulation(TENS) device |
| Control group(B) | Sham comparator | The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation Receives: Device: Transcutaneous Electrical Nerve Stimulation(TENS) device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red cell distribution width (RDW)
Peripheral venous blood samples were obtained from each patient.
Measured: change from baseline to after 12 weeks
Mean platelet volume(MPV)
Peripheral venous blood samples were obtained from each patient.
Measured: change from baseline to after 12 weeks
Ankle peak systolic velocity (APSV)
is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography
Measured: change from baseline to after 12 weeks
Arterial diameter
Diameter of lower limb arteries measured by doppler ultrasonography
Measured: change from baseline to after 12 weeks
Secondary outcomes (1)
Actual claudication distance
Claudication pain distance was measured after running on a treadmill constant walking speed of 2 mile/hour at 0% grade, with gradual increases in grade of 2.0% every 2 minutes.
Measured: change from baseline to after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start20 Jan 2021
- Primary completion12 May 2021
- Study completion20 May 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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Ahmed Ali Abdeen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830254
- Sponsor's protocol ID
- TENS21
- Status last verified
- Jul 2021
- First submitted
- 31 Mar 2021
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- 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 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients
- ClinicalTrials.gov ID
- NCT04830254
- Acronym / sponsor ID
- TENS21
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 5 Apr 2021 (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.
Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.
Detailed description
The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group(A) | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation(TENS) deviceGroup (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks. |
| Control group(B) | Sham comparator | Device: Transcutaneous Electrical Nerve Stimulation(TENS) deviceThe control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Unilateral Leriche-Fontaine stage-II PAD
- Both sexes
- Aged 50 to 60 years
- Outpatients
- Clinically stable
Key exclusion criteria (9 listed)
- Walking disorders related to orthopedic or neuromuscular disease
- Renal insufficiency requiring dialysis (Renal diseases)
- Known and documented myopathy
- Progressive cancer
- Associated progressive disease causing a deterioration in general health
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation(TENS) deviceAlso: TENSThe Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks. | Device | Control group(B), study group(A) |
Primary outcome
Red cell distribution width (RDW)
Time frame: change from baseline to after 12 weeks
Peripheral venous blood samples were obtained from each patient.
Mean platelet volume(MPV)
Time frame: change from baseline to after 12 weeks
Peripheral venous blood samples were obtained from each patient.
Ankle peak systolic velocity (APSV)
Time frame: change from baseline to after 12 weeks
is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography
Arterial diameter
Time frame: change from baseline to after 12 weeks
Diameter of lower limb arteries measured by doppler ultrasonography
1 secondary outcome
Actual claudication distance
Time frame: change from baseline to after 12 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 27 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation(TENS) device in people with Peripheral Arterial Disease, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 9 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 27 Jul 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Red cell distribution width (RDW) (time frame: change from baseline to after 12 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 27 Jul 2021.