DiabetesNCT01868698
Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women
A study testing high-voltage electrical stimulation, Kinesiotherapy and shortwave diathermy in people with Diabetes and Peripheral Arterial Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Diabetes, Peripheral Arterial Disease
- What is being tested?
- high-voltage electrical stimulation, Kinesiotherapy and shortwave diathermy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2009to Jan 2012
- 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 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Diagnosis of diabetes
- Diagnosis of peripheral arterial disease
Who cannot join
- Regular physical activity
- Smokers
- Thrombosis active
- Severe peripheral arterial disease
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.
- Conditions
- Diabetes, Peripheral Arterial Disease
- Being tested
- high-voltage electrical stimulation, Kinesiotherapy, shortwave diathermy
- Keywords
- Physical Therapy Modalities, Electric Stimulation Therapy, Hyperthermia, Induced, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Peripheral Arterial Disease, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-voltage electrical stimulationOther
KinesiotherapyOther
shortwave diathermyOther
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotherapy | Experimental | Will be made active and resisted exercises of the lower limbs. Receives: Other: Kinesiotherapy |
| shortwave diathermy | Experimental | Will be applied for 20 minutes on the lower limbs. Receives: Other: shortwave diathermy |
| high-voltage electrical stimulation | Experimental | The therapeutic current will be applied for 20 minutes on lower limbs. Receives: Other: high-voltage electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doppler ultrasound
Will evaluate the blood flow in the following arteries of the lower limbs: femoral, popliteal, posterior tibial and dorsalis pedis.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Rinaldo Guirro, PhD, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868698
- Sponsor's protocol ID
- U1111-1143-8004
- Status last verified
- May 2013
- First submitted
- 30 May 2013
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Voltage Electrical Stimulation, Shortwave Diathermy and Kinesiotherapy on Arterial Blood Flow in the Lower Limbs of Diabetic Women
- ClinicalTrials.gov ID
- NCT01868698
- Acronym / sponsor ID
- U1111-1143-8004
- Conditions
- Diabetes, Peripheral Arterial Disease
- Keywords
- Physical Therapy Modalities, Electric Stimulation Therapy, Hyperthermia, Induced, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Jun 2013 (estimated)
- 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.
Peripheral arterial disease (PAD) is a pathological condition limiting, resulting from a narrowing or occlusion of the artery diameter due to aneurysms, inflammation, atherosclerosis and thromboembolic events. One of the main risk factors for the development of DAP is diabetes mellitus due to its relation to the process of atherogenesis. Thus, the objective of this study is to evaluate the effects of three treatment modalities for PAD on the blood flow velocity. It is a crossover study. Fifteen women with diabetes receive three types of treatment, the order defined according draw: high voltage electrical stimulation, shortwave diathermy and kinesiotherapy. The blood flow of the lower limb will be assessed by Doppler ultrasound. The hypothesis of this study is that physical therapy resources increase the circulation of the lower limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kinesiotherapy | Experimental | Other: KinesiotherapyWill be made active and resisted exercises of the lower limbs. |
| shortwave diathermy | Experimental | Other: shortwave diathermyWill be applied for 20 minutes on the lower limbs. |
| high-voltage electrical stimulation | Experimental | Other: high-voltage electrical stimulationThe therapeutic current will be applied for 20 minutes on lower limbs. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women
- Diagnosis of diabetes
- Diagnosis of peripheral arterial disease
Key exclusion criteria (4 listed)
- Regular physical activity
- Smokers
- Thrombosis active
- Severe peripheral arterial disease
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 |
|---|---|---|
| high-voltage electrical stimulation | Other | high-voltage electrical stimulation |
| Kinesiotherapy | Other | Kinesiotherapy |
| shortwave diathermy | Other | shortwave diathermy |
Primary outcome
Doppler ultrasound
Time frame: 1 years
Will evaluate the blood flow in the following arteries of the lower limbs: femoral, popliteal, posterior tibial and dorsalis pedis.
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 4 Jun 2013.
- Related InfoLink provided by the sponsor.
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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.
Rinaldo Guirro, PhD, Professor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-voltage electrical stimulation, Kinesiotherapy and shortwave diathermy in people with Diabetes and Peripheral Arterial Disease, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 4 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 4 Jun 2013. 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 Brazil. 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?
Doppler ultrasound (time frame: 1 years). 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 4 Jun 2013.