Diabetic FootNCT02432859
Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
A study testing Electrical Stimulation in people with Diabetic Foot, run by Tarbiat Modarres University at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Electrical Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Nov 2013to Feb 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic diabetic foot ulcer
- Wagner classification DFU 2
- 0.5<ABI<0.9
- Mild to moderate diabetic neuropathy
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 Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.
Read the detailed description
30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) was measured at 1st, 6th, and 12th session.
- Conditions
- Diabetic Foot
- Being tested
- Electrical Stimulation, 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 StimulationProcedure or surgery
Also called Direct current ES
Direct current with sensory intensity for one hour
PlaceboProcedure or surgery
Also called Placebo Direct current ES
Direct current with zero intensity for one hour
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Active comparator | In the 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: Procedure: Electrical Stimulation |
| 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: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
Measured: Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
Secondary outcomes (1)
Wound surface area(cm2)
Measured: Change from Baseline in wound surface area at 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarbiat Modarres University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT02432859
- Sponsor's protocol ID
- D52/2509
- Status last verified
- Jul 2015
- First submitted
- 16 Apr 2015
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT02432859
- Acronym / sponsor ID
- D52/2509
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tarbiat Modarres UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 May 2015 (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.
The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.
Detailed description
30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) was measured at 1st, 6th, and 12th session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Active comparator | Procedure: Electrical StimulationIn the 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 | Procedure: 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 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic diabetic foot ulcer
- Wagner classification DFU 2
- 0.5<ABI<0.9
- Mild to moderate diabetic neuropathy
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 StimulationAlso: Direct current ESDirect current with sensory intensity for one hour | Procedure or surgery | Electrical stimulation |
| PlaceboAlso: Placebo Direct current ESDirect current with zero intensity for one hour | Procedure or surgery | Placebo |
Primary outcome
The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
Time frame: Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
1 secondary outcome
Wound surface area(cm2)
Time frame: Change from Baseline in wound surface area at 2 and 4 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 31 Jul 2015.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
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 in people with Diabetic Foot, run by Tarbiat Modarres University 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 4 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 31 Jul 2015. 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 wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml) (time frame: Change from Baseline in wound fluid level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks). 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 31 Jul 2015.