Object: the effect of diabetic socks on plantar pressure distribution in people with diabetic neuropathy.
Study design: the study is an experimental study in type of time series.
Study population: patients with diabetic neuropathy.
Inclusion criteria: women or men with type II diabetes based on WHO criteria; age in the range of 35 to 85 years of old and period of diabetes between 11-32 years; the absence of previous wounds in the leg and based on clinical examination (degree of zero based on maggitt wagner index); no history of medical use of shoes or insoles; the risk of neuropathy and the inability to detect Monofilaments with a diameter of 5.07 or Pressure of 10 grams using the Semmes Weinstein Monofilaments. Exclusion criteria: inability to walk for any reason.
Sample size: 25.
Intervention: diabetic socks
The primary outcome or study outcomes: determine the pressure foot with diabetic neuropathy before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051515329N2
Registration date:2016-07-11, 1395/04/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-11, 1395/04/21
Registrant information
Name
Sedigheh sadat Mirbagheri
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 1572
Email address
s.mirbagheri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diabetic socks on plantar pressure distribution in people with diabetic neuropathy .
Public title
The effect of diabetic socks on plantar pressure in people with diabete.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: female or male with type 2 diabetes according to WHO criteria; age between 35 - 85 years old and duration of diabetes between 11- 32 years; absence of previous wounds in the leg and wound based on clinical examination (zero based on Meggitt Wagner); neuropathy and inability to recognize Monofilament with a diameter of 5.07 or 10 grams pressure using the Semmes Weinstein Monofilaments; no history of medical use of shoes or insoles.
Exclusion criteria: need for walking aids; non-diabetes-related pain or injury in the leg while walking; foot ulcer causes other than diabetes; Charcot neuropathy with clinical symptoms such as unilateral swelling, increase in skin temperature, arrhythmia and joint effusion; severe deformity such as Claw toe and Hammer toe to prevent wearing standard
shoe.
Age
From 35 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences.
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street.
City
Hamadan
Postal code
Approval date
2016-06-23, 1395/04/03
Ethics committee reference number
IR.UMSHA.REC.1395.124
Health conditions studied
1
Description of health condition studied
Diabete mellitus type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Max plantar pressure
Timepoint
Before and after intervention
Method of measurement
Foot pressure measuring system
Secondary outcomes
empty
Intervention groups
1
Description
Using diabetic socks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini clinic
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and technology
Full name of responsible person
Saeed Bashirian
Street address
Vice chancellor for research and technology, University of medical sciences, Shahid Fahmideh Street, Hamadan.
City
Hamadan
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 and technology
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
School of Rehabilitation
Full name of responsible person
Sedigheh Sadat Mirbagheri
Position
Faculty/ Master of Science
Other areas of specialty/work
Street address
Department of Orthotics and Prosthetics, School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Street.
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
smirbagheri110@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences.
Full name of responsible person
Sedigheh Sadat Mirbagheri
Position
Faculty/ Master of Sciences.
Other areas of specialty/work
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Street.
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
smirbagheri110@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences.
Full name of responsible person
Sedigheh Sadat Mirbagheri
Position
Faculty/ Master of Sciences.
Other areas of specialty/work
Street address
School of Rehabilitation, Hamadan University of Medical Sciences, Shahid Fahmideh Street.
City
Hamadan
Postal code
Phone
+98 81 3838 1571
Fax
Email
smirbagheri110@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)