Trial Outcomes & Findings for Development and Testing of a New Generation of Diabetic Footwear (NCT NCT01816906)
NCT ID: NCT01816906
Last Updated: 2019-06-14
Results Overview
Postural sway was recorded while standing on a pressure mat with eyes open for 30 seconds. Area of the center of pressure excursion
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
82 participants
Primary outcome timeframe
6 months
Results posted on
2019-06-14
Participant Flow
Participant milestones
| Measure |
MCP Insole
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
|
PU Insole
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.
|
|---|---|---|
|
Six Months
STARTED
|
41
|
41
|
|
Six Months
COMPLETED
|
20
|
19
|
|
Six Months
NOT COMPLETED
|
21
|
22
|
|
12 Months
STARTED
|
20
|
19
|
|
12 Months
COMPLETED
|
16
|
14
|
|
12 Months
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
MCP Insole
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
|
PU Insole
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.
|
|---|---|---|
|
Six Months
Did Not Show Up for Baseline Measurement
|
7
|
6
|
|
Six Months
Lost to Follow-up
|
14
|
16
|
|
12 Months
Adverse Event
|
2
|
2
|
|
12 Months
Death
|
0
|
2
|
|
12 Months
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Development and Testing of a New Generation of Diabetic Footwear
Baseline characteristics by cohort
| Measure |
MCP Insole
n=34 Participants
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
|
PU Insole
n=35 Participants
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
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Height
|
1.63 meters
STANDARD_DEVIATION 0.09 • n=5 Participants
|
1.67 meters
STANDARD_DEVIATION 0.08 • n=7 Participants
|
1.65 meters
STANDARD_DEVIATION 0.09 • n=5 Participants
|
|
Weight
|
73 Kilogram
STANDARD_DEVIATION 11 • n=5 Participants
|
77 Kilogram
STANDARD_DEVIATION 13 • n=7 Participants
|
75 Kilogram
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Duration of Diabetes
|
13.3 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
12.2 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
12.8 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPostural sway was recorded while standing on a pressure mat with eyes open for 30 seconds. Area of the center of pressure excursion
Outcome measures
| Measure |
MCP Insole
n=20 Participants
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
|
PU Insole
n=19 Participants
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.
|
|---|---|---|
|
Postural Sway During Shod Standing
|
4.3 cm^2
Standard Deviation 2.8
|
3.1 cm^2
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Up to 6 monthsStrength during dorsi flexion using Citec Dynamometer
Outcome measures
| Measure |
MCP Insole
n=20 Participants
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
|
PU Insole
n=19 Participants
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.
|
|---|---|---|
|
Ankle Strength Left 1
|
111 N
Standard Deviation 40
|
116 N
Standard Deviation 44
|
SECONDARY outcome
Timeframe: Up to 6 monthsStrength during plantar flexion using Citec Dynamometer
Outcome measures
| Measure |
MCP Insole
n=20 Participants
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
|
PU Insole
n=19 Participants
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.
|
|---|---|---|
|
Ankle Strength Left 2
|
135 N
Standard Deviation 47
|
140 N
Standard Deviation 52
|
SECONDARY outcome
Timeframe: Up to 6 monthsStrength during dorsi flexion using Citec Dynamometer
Outcome measures
| Measure |
MCP Insole
n=20 Participants
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
|
PU Insole
n=19 Participants
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.
|
|---|---|---|
|
Ankle Strength Right 1
|
107 N
Standard Deviation 37
|
110 N
Standard Deviation 39
|
SECONDARY outcome
Timeframe: Up to 6 monthsStrength during plantar flexion using Citec Dynamometer
Outcome measures
| Measure |
MCP Insole
n=20 Participants
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
|
PU Insole
n=19 Participants
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.
|
|---|---|---|
|
Ankle Strength Right 2
|
132 N
Standard Deviation 45
|
141 N
Standard Deviation 47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 monthsAverage of left and right (8 measurement areas per foot)
Outcome measures
| Measure |
MCP Insole
n=20 Participants
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
|
PU Insole
n=19 Participants
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.
|
|---|---|---|
|
Vibration Perception Threshold
|
53 V
Standard Deviation 19
|
65 V
Standard Deviation 19
|
Adverse Events
MCP Insole
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
PU Insole
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
MCP Insole
n=34 participants at risk
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
|
PU Insole
n=35 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Ulceration
|
5.9%
2/34 • 2 years
|
5.7%
2/35 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Professor Nachiappan Chockalingam
Staffordshire University
Phone: +44 1782 295853
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place