Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
The Effect of Electrical Stimulation on the Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 16, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedJuly 31, 2015
July 1, 2015
10 months
April 16, 2015
July 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The wound fluid level of VEGF, VEGFR-2, HIF-1α and NO (pg/ml)
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)
Change from Baseline in wound surface area at 2 and 4 weeks
Study Arms (2)
Electrical stimulation
ACTIVE COMPARATORIn 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 COMPARATORIn the placebo group, the treatment procedure was the same as that the ES group, but the current intensity was zero
Interventions
Direct current with sensory intensity for one hour
Direct current with zero intensity for one hour
Eligibility Criteria
You may qualify if:
- Ischemic diabetic foot ulcer
- Wagner classification DFU 2
- \<ABI\<0.9
- Mild to moderate diabetic neuropathy
You may not qualify if:
- Fracture in a lower limb
- A severe infection
- A malignancy
- Kidney failure
- Skin diseases
- Osteomyelitis
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tarbiat Modares University
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Giti Torkaman, PhD
Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity
Study Record Dates
First Submitted
April 16, 2015
First Posted
May 4, 2015
Study Start
November 1, 2013
Primary Completion
September 1, 2014
Study Completion
February 1, 2015
Last Updated
July 31, 2015
Record last verified: 2015-07