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Trial record 5 of 66 for:    strength | ( Map: India )

Development and Testing of a New Generation of Diabetic Footwear (DiaBSmart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01816906
Recruitment Status : Completed
First Posted : March 22, 2013
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Information provided by (Responsible Party):
Nachiappan Chockalingam, Staffordshire University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diabetes Complications
Diabetic Neuropathies
Interventions Device: Footwear :PU
Device: Footwear: MCP
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles.

Period Title: Six Months
Started 41 41
Completed 20 19
Not Completed 21 22
Reason Not Completed
Did Not Show Up for Baseline Measurement             7             6
Lost to Follow-up             14             16
Period Title: 12 Months
Started 20 19
Completed 16 14
Not Completed 4 5
Reason Not Completed
Adverse Event             2             2
Death             0             2
Lost to Follow-up             2             1
Arm/Group Title MCP Insole PU Insole Total
Hide Arm/Group Description

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles

Total of all reporting groups
Overall Number of Baseline Participants 34 35 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  76.5%
31
  88.6%
57
  82.6%
>=65 years
8
  23.5%
4
  11.4%
12
  17.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 35 participants 69 participants
60.4  (8.7) 56.1  (7.2) 58.3  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 35 participants 69 participants
Female
16
  47.1%
11
  31.4%
27
  39.1%
Male
18
  52.9%
24
  68.6%
42
  60.9%
Height  
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 34 participants 35 participants 69 participants
1.63  (0.09) 1.67  (0.08) 1.65  (0.09)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 34 participants 35 participants 69 participants
73  (11) 77  (13) 75  (12)
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 35 participants 69 participants
13.3  (7.8) 12.2  (6.0) 12.8  (6.9)
1.Primary Outcome
Title Postural Sway During Shod Standing
Hide Description

Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds.

Area of the center of pressure excursion

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description:

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles.

Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: cm^2
4.3  (2.8) 3.1  (2.7)
2.Secondary Outcome
Title Ankle Strength Left 1
Hide Description Strength during dorsi flexion using Citec Dynamometer
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description:

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles

Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: N
111  (40) 116  (44)
3.Secondary Outcome
Title Ankle Strength Left 2
Hide Description Strength during plantar flexion using Citec Dynamometer
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description:

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles

Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: N
135  (47) 140  (52)
4.Secondary Outcome
Title Ankle Strength Right 1
Hide Description Strength during dorsi flexion using Citec Dynamometer
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description:

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles

Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: N
107  (37) 110  (39)
5.Secondary Outcome
Title Ankle Strength Right 2
Hide Description Strength during plantar flexion using Citec Dynamometer
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description:

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles

Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: N
132  (45) 141  (47)
6.Other Pre-specified Outcome
Title Vibration Perception Threshold
Hide Description Average of left and right (8 measurement areas per foot)
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description:

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles

Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: V
53  (19) 65  (19)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MCP Insole PU Insole
Hide Arm/Group Description

The intervention is "Footwear: MCP". MCP insoles are commonly used within Diabetic sandals in India.

Footwear: MCP: One group of patients will receive footwear with MCP insoles

The intervention is "Footwear: PU". Insoles made of Polyurethane(PU) are given to the participants in the intervention arm.

Footwear :PU: One group of patients will receive "Footwear" with PU insoles.

All-Cause Mortality
MCP Insole PU Insole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   2/35 (5.71%) 
Show Serious Adverse Events Hide Serious Adverse Events
MCP Insole PU Insole
Affected / at Risk (%) Affected / at Risk (%)
Total   2/34 (5.88%)   2/35 (5.71%) 
Skin and subcutaneous tissue disorders     
Ulceration *  2/34 (5.88%)  2/35 (5.71%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MCP Insole PU Insole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)   0/35 (0.00%) 
Technical problems with in-shoe plantar pressure measurements lead to unreliable data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Nachiappan Chockalingam
Organization: Staffordshire University
Phone: +44 1782 295853
EMail: n.chockalingam@staffs.ac.uk
Publications of Results:
Naemi, R., Linyard-Tough, K., Healy, A. and Chockalingam, N., 2015. The influence of slow recovery insole on plantar pressure and contact area during walking. Journal of Mechanics in Medicine and Biology, 15(02), p.1540005.
Layout table for additonal information
Responsible Party: Nachiappan Chockalingam, Staffordshire University
ClinicalTrials.gov Identifier: NCT01816906     History of Changes
Other Study ID Numbers: DiaBSmart-01
DiaBSmart -2011-IAPP ( Other Grant/Funding Number: FP7-PEOPLE-2011-IAPP Grant Agreement Number 285985 )
First Submitted: March 14, 2013
First Posted: March 22, 2013
Results First Submitted: September 6, 2018
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019