Objective: Diabetic foot ulcer is one of serious complication of diabetes. This study aimed to investigate the effect of cathodal direct current on the skin temperature and accelerates wound closure in the ischemic diabetic foot ulcer.
Design: This the one-blind randomized controlled trial conducted in 2014.
Setting and conduct: 20 patient with ischemic diabetic foot ulcer were randomly assigned to the electrical stimulation or placebo groups.
Participants including major eligibility criteria: Ischemic diabetic foot ulcer; Wagner classification DFU 2; both sex; mild to moderate diabetic neuropath.
Exclusion criteria: Skin diseases; osteomyelitis; angioplasty.
Intervention: In the electrical stimulation group, cathodal direct current with sensory threshold intensity applied to the wound site for 1 h/day, 3 days/week and for 12 sessions. In the placebo group, the treatment procedure was the same as that described for the electrical stimulation group, but the current intensity was zero.
Main outcome (measures variables): Skin temperature in plantar and dorsal foot, before and after intervention, and the wound surface area was measured at 1st, 6th and 12th sessions.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110819854N1
Registration date:2014-12-07, 1393/09/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-07, 1393/09/16
Registrant information
Name
Mohammadreza Asadi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 8531
Email address
mohammadreza.asadi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tarbiat Modares University
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-09-12, 1393/06/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cathodal direct current on the skin temperature and healing in ischemic diabetic foot ulcer, one-blind controlled trial
Public title
The effect of electrical stimulation on diabetic foot ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
The main inclusion criteria: Patients with ischemic diabetic foot ulcer; Wagner classification DFU 2; both sex; mild to moderate diabetic neuropathy; 0.7< ankle-brachial index<0.9; HbA1c < 8.2.
The main exclusion criteria: Fracture in a lower limb; severe infection; malignancy; kidney failure; skin diseases; osteomyelitis; angioplasty.
Age
From 40 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
Facualty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Approval date
2013-07-06, 1392/04/15
Ethics committee reference number
52/2570
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
E10, E11,
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Skin temperature
Timepoint
Befor and after intervention, 6 and 12 days following onset of intervention
Method of measurement
Centigrade by thermometer
Secondary outcomes
1
Description
Wound surface area
Timepoint
One, 6 and 12 following onset of intervention
Method of measurement
Square centimeter by standard ruler
Intervention groups
1
Description
In the electrical stimulation group, an active carbon rubberized electrode (3 × 4 cm) was placed just outside the ulcer surface area. A dispersive electrode (4 × 6 cm) was placed approximately 20 cm proximal to the active electrode and far from the wound on the proximal region of the leg. The polarity of the active electrode was negative (cathode) during the treatment period. Cathodal direct current with sensory threshold intensity applied to the wound site for 1 h/day, 3 days/week and for 12 sessions.
Category
Treatment - Other
2
Description
In placebo group, an active carbon rubberized electrode (3 × 4 cm) was placed just outside the ulcer surface area. A dispersive electrode (4 × 6 cm) was placed approximately 20 cm proximal to the active electrode and far from the wound on the proximal region of the leg. In the placebo group, the treatment procedure was the same as that described for the electrical stimulation group, but the current intensity was zero.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic foot ulcer clinic, Hajar haspital
Full name of responsible person
Mrs. Fathi; Nerse Supervisor
Street address
First of Doctor Beheshti Street, Valiasser Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tarbiat Modares University
Full name of responsible person
Seyid Saeed Mosavian
Street address
Vice chancellor for research, Faculty of Medical Sciences (1), Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammadreza Asadi
Position
PhD Student
Other areas of specialty/work
Street address
Physical Therapy Department, Facualty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Phone
+98 21 8288 3824
Fax
Email
Mohammadreza.asadi@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Giti Torkaman
Position
Professor
Other areas of specialty/work
Street address
Physical Therapy Department, Facualty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Phone
+98 21 8288 4509
Fax
+98 21 8288 4555
Email
Torkamg@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammadreza Asadi
Position
PhD Student
Other areas of specialty/work
Street address
Physical Therapy Department, Facualty of Medical Sciences, Tarbiat Modares University, Jalal Ale Ahmad Highway
City
Tehran
Postal code
Phone
+98 21 8288 3824
Fax
Email
Reza.asadi21@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)