Electrical Stimulation and Expression of VEGF and NO in Diabetic Foot Ulcer

NCT02019082 | Completed DMC

• 1 other identifier: د 50/259
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• The plasma level of VEGF(pg/ml) and NO (microM)

  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)

  prior the 1st electrical stimulation session (day 1) and 1 hour later

• skin temperature (degree of centigrade)

  prior the 6th electrical stimulation session (day 12) and 1 hour later

• skin temperature (degree of centigrade)

  prior the 12th electrical stimulation session (day 26) and 1 hour later

• Wound surface area(cm2)

  on day 1, 12, and 26

Study Arms (2)

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)

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.

Device: placebo

Interventions

Electrical Stimulation (BTL-5000 series, United Kingdom) DEVICE

Direct current ES

electrical stimulation

placebo DEVICE

the intervention procedure was the same as that the ES group, but the current intensity was zero

placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Wagner classification DFU 2;
• age 40-60 years;
• mild to moderate diabetic neuropathy;
• ABI\>0.7
• wound surface area\>1.5cm2

You may not qualify if:

• fracture in a lower limb,
• a severe infection,
• a malignancy,
• kidney failure,
• skin diseases,
• osteomyelitis,
• pregnancy,

Sponsors & Collaborators

• giti torkaman: lead

Study Sites (1)

Physical Therapy Department, Faculty of Medical Sciences

Tehran, Iran

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• giti torkaman, PhD

  professor of physical therapy, physical therapy department, faculty of medical sciences, tarbiat modares univercity

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: December 24, 2013
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

IR (1)