Diabetic Foot UlcerNCT02019082
Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer
A study testing Electrical Stimulation (BTL-5000 series, United Kingdom) in people with Diabetic Foot Ulcer, run by giti torkaman at 1 site in Iran.
Trial summary
This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Electrical Stimulation (BTL-5000 series, United Kingdom)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Dec 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Wagner classification DFU 2;
- age 40-60 years;
- mild to moderate diabetic neuropathy;
- ABI>0.7
- wound surface area>1.5cm2
Who cannot join
- fracture in a lower limb,
- a severe infection,
- a malignancy,
- kidney failure,
- skin diseases,
- osteomyelitis,
- pregnancy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Low-intensity Direct Current on the Expression of Vascular Endothelial Growth Factor and Nitric Oxide in Diabetic Foot Ulcers
This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.
Read the detailed description
Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) and skin temperature were measured at 1st, 6th, and 12th session.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Electrical Stimulation (BTL-5000 series, United Kingdom), placebo
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Stimulation (BTL-5000 series, United Kingdom)Device
Direct current ES
placeboDevice
the intervention procedure was the same as that the ES group, but the current intensity was zero
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation | Active comparator | electrical stimulation group, group who received direct current ES at sensory threshold intensity for 1 h/day, 3 days/week, for 4 weeks (12 sessions) Receives: Device: Electrical Stimulation (BTL-5000 series, United Kingdom) |
| placebo | Placebo comparator | In the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero. Receives: Device: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma level of VEGF(pg/ml) and NO (microM)
Measured: prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later
Secondary outcomes (4)
skin temperature (degree of centigrade)
Measured: prior the 1st electrical stimulation session (day 1) and 1 hour later
skin temperature (degree of centigrade)
Measured: prior the 6th electrical stimulation session (day 12) and 1 hour later
skin temperature (degree of centigrade)
Measured: prior the 12th electrical stimulation session (day 26) and 1 hour later
Wound surface area(cm2)
Measured: on day 1, 12, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- giti torkaman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, giti torkaman, Tarbiat Modarres University
- Investigators
- giti torkaman, PhD, Study director, professor of physical therapy, physical therapy department, faculty of medical sciences, tarbiat modares univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019082
- Sponsor's protocol ID
- د 50/259
- Status last verified
- Dec 2013
- First submitted
- 9 Oct 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-intensity Direct Current on the Expression of Vascular Endothelial Growth Factor and Nitric Oxide in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02019082
- Acronym / sponsor ID
- د 50/259
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- giti torkamanUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Dec 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.
This study aimed to investigate the effect of low intensity cathodal direct current on the release of plasma vascular endothelial growth factor (VEGF) and nitric oxide (NO) in diabetic foot ulceration.
Detailed description
Twenty type 2 diabetic patients with foot ulceration and 13 age-matched healthy subjects were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=10) or sham ES (placebo, n=10) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Blood sample was collected for VEGF and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) and skin temperature were measured at 1st, 6th, and 12th session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation | Active comparator | Device: Electrical Stimulation (BTL-5000 series, United Kingdom)electrical stimulation group, group who received direct current ES at sensory threshold intensity for 1 h/day, 3 days/week, for 4 weeks (12 sessions) |
| placebo | Placebo comparator | Device: placeboIn the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Wagner classification DFU 2;
- age 40-60 years;
- mild to moderate diabetic neuropathy;
- ABI>0.7
- wound surface area>1.5cm2
Key exclusion criteria (7 listed)
- fracture in a lower limb,
- a severe infection,
- a malignancy,
- kidney failure,
- skin diseases,
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 |
|---|---|---|
| Electrical Stimulation (BTL-5000 series, United Kingdom)Direct current ES | Device | electrical stimulation |
| placebothe intervention procedure was the same as that the ES group, but the current intensity was zero | Device | placebo |
Primary outcome
The plasma level of VEGF(pg/ml) and NO (microM)
Time frame: prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later
4 secondary outcomes
skin temperature (degree of centigrade)
Time frame: prior the 1st electrical stimulation session (day 1) and 1 hour later
skin temperature (degree of centigrade)
Time frame: prior the 6th electrical stimulation session (day 12) and 1 hour later
skin temperature (degree of centigrade)
Time frame: prior the 12th electrical stimulation session (day 26) and 1 hour later
Wound surface area(cm2)
Time frame: on day 1, 12, and 26
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 24 Dec 2013.
Related trials for Diabetic Foot Ulcer
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
giti torkaman, PhD study director
professor of physical therapy, physical therapy department, faculty of medical sciences, tarbiat modares univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation (BTL-5000 series, United Kingdom) in people with Diabetic Foot Ulcer, run by giti torkaman at 1 site in Iran.
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 5 inclusion and 7 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 24 Dec 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 Iran. 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?
The plasma level of VEGF(pg/ml) and NO (microM) (time frame: prior to the 1st electrical stimulation session(day 1) and 1 hour later, and prior to the 12th electrical stimulation session(day 26) and 1 hour later). 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 24 Dec 2013.