Comparison of pressure exerted on the sole of the foot between individuals with and without blood sugar

Not yet recruiting

Conditions: without Diabetes Mellitus
with Type 2 Diabetes Mellitus

Registration Number: CTRI/2017/09/009899

Lead Sponsor: Sophia Anne Francis

Brief Summary: Potential participants will be screened based on the inclusion and exclusion criteria. The selected participants will be explained about the study and a written informed consent will be obtained for their participation. Demographic details of the participants will be obtained which include, age, height, weight, BMI and foot type.

Participants with T2DM will be asked to stand on the platform and the instructions will be given to look at a fixed point on the wall marked at eye level at a distance of two meters. Platform is switched on and the pressures on the different foot pressure points will be recorded. After recording, participants will be asked to step down the platform and relax.

The same procedure will be repeated in individuals without diabetes who are age, gender, BMI and foot type matched. The amount of pressure recorded from different areas of foot in individuals with and without T2DM will be subjected to data analysis. Amount of pressure in different areas of foot in kilo pascals will be recorded.

SPSS version 16 will be used for data analysis. Descriptive statistics will be used to summarize the demographic variables and quantify the pressure in different areas of foot. Independent t test will be used to compare the pressure in different areas of foot in individuals with and without T2DM. Level of significance will be set at p < 0.05 for the analysis.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

Individuals with Diabetes: -Diagnosed to have Type 2 Diabetes Mellitus for the past six months Individuals without Diabetes: -Non- diabetic as reported by the individuals -Blood sugar level report indicating non- diabetic -Age, gender, BMI and foot type matched with T2DM.

Exclusion Criteria

Individuals with Diabetes: -Foot deformities -Any neurological, orthopedic or cardiopulmonary conditions which prevent the individuals from standing -Lower limb surgeries underwent in less than 6 months Individuals without Diabetes: -Pes planus or Pescavus or any other foot deformities -Any conditions which prevent the individuals from standing.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of pressure in different areas of foot in kilo pascals.	One time point.

Secondary Outcome Measures

Name	Time	Method
Amount of pressure in different areas of foot in kilo pascals.	one time point.

Trial Locations

Locations (1): Diabetic Foot Clinic
🇮🇳
Udupi, KARNATAKA, India
Diabetic Foot Clinic
🇮🇳Udupi, KARNATAKA, India
Sophia Anne Francis
Principal investigator
7624846456
sophia_anne5@hotmail.com