Electrical Stimulation and Expression of VEGF, VEGFR-2, H... | NCT02432859

Studies
Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer

NCT02432859

Sponsor

Tarbiat Modarres University

Status

Completed

Last Update Posted

Jul 31, 2015Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Diabetic Foot

Interventions

Electrical Stimulation
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Sep 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Apr 16, 2015

First Submission Date that Met QC Criteria

May 1, 2015

First Posted Date

May 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

giti torkaman, Professor of physical therapy, Physical therapy department, Faculty of medical sciences, Tarbiat modares univercity, Tarbiat Modarres UniversityPrincipal Investigator

Lead Sponsor

Tarbiat Modarres UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)	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	Procedure: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electrical Stimulation	Procedure	Direct current with sensory intensity for one hour	Electrical stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Wound surface area(cm2)		Change from Baseline in wound surface area at 2 and 4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ischemic diabetic foot ulcer
Wagner classification DFU 2
0.5\

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giti Torkaman, PhD	Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tarbiat Modares University		Tehran			Iran

Condition Browse Module

MeSH Terms

ID	Term
D017719	Diabetic Foot

Ancestor Terms

ID	Term
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016523	Foot Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004558	Electric Stimulation

Ancestor Terms

ID	Term
D010812	Physical Stimulation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided