Trial Outcomes & Findings for Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer (NCT NCT01844479)

Results Overview

Plantar foot temperature changes in regions-of-interest in response to walking 200 steps will be measured in each footwear condition and compared to baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

baseline and after 200 steps in each condition, this is a single visit study expected to last one hour

Results posted on

2016-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Innersole Followed by DFO The industry standard diabetic innersole will be used as the active comparator Standard innersole DFO The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.	Diabetic Foot Orthotic Followed by Standard Innersole The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load. The industry standard diabetic innersole will be used as the active comparator Standard innersole
First Intervention up to 30 Minutes STARTED	14	13
First Intervention up to 30 Minutes COMPLETED	14	13
First Intervention up to 30 Minutes NOT COMPLETED	0	0
Second Intervention up to 30 Minutes STARTED	14	13
Second Intervention up to 30 Minutes COMPLETED	14	13
Second Intervention up to 30 Minutes NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Age, Continuous	65.1 years n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	14 Participants n=99 Participants

PRIMARY outcome

Timeframe: baseline and after 200 steps in each condition, this is a single visit study expected to last one hour

Plantar foot temperature changes in regions-of-interest in response to walking 200 steps will be measured in each footwear condition and compared to baseline.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking	0.758 Absolute change in temperature degrees Standard Deviation 1.48	0.272 Absolute change in temperature degrees Standard Deviation 1.21

SECONDARY outcome

Timeframe: during each foot wear condition up to 30 minutes

The number of steps taken to reach steady state walking under single task. Single task means walking without a simultaneous mental task.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Gait Initation - Single Task	4.53 Number of steps Standard Deviation 0.63	4.32 Number of steps Standard Deviation 0.58

SECONDARY outcome

Timeframe: during each foot wear condition up to 30 minutes

The number of steps taken to reach steady state walking under dual task. Dual task used a simultaneous mental task while walking.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Gait Initiation - Dual Task	3.58 Number of steps Standard Deviation 0.53	3.42 Number of steps Standard Deviation 0.58

SECONDARY outcome

Timeframe: during each foot wear condition up to 30 minutes

Stride velocity during steady state dual task. Dual task used a simultaneous mental task while walking.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Stride Velocity - Dual Task	1.01 m/s Standard Deviation 0.05	1.00 m/s Standard Deviation 0.04

SECONDARY outcome

Timeframe: during each foot where condition up to 30 minutes

percentage of stride time spent in double support time during gait initiation. Double support time refers to the time spent with both feet on the ground. Single task means walking without a simultaneous mental task.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Double Support Time Single Task	31.6 percentage of stride time Standard Deviation 2.4	28.3 percentage of stride time Standard Deviation 1.3

SECONDARY outcome

Timeframe: during each foot where condition up to 30 minutes

percentage of stride time spent in double support time during dual task conditions and during gait initiation. Double support time refers to the time spent with both feet on the ground. Dual task used a simultaneous mental task while walking.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Double Support Time Dual Task Gait Initiation	31.5 percentage of stride time Standard Deviation 2.2	29.8 percentage of stride time Standard Deviation 1.3

SECONDARY outcome

Timeframe: under each foot where condition up to 30 minutes

Mediolateral (side-to-side) center of mass displacement with displacement in deg2 (degrees squared) under single task gait conditions. Single task means walking without a simultaneous mental task.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Medial and Lateral Center of Mass Displacement Single Task	4.60 deg2 Standard Deviation 0.48	4.61 deg2 Standard Deviation 0.36

SECONDARY outcome

Timeframe: both footwear conditions up to 30 minutes

Mediolateral (side-to-side) center of mass displacement in deg2 (degrees squared) under dual task gait. Dual task used a simultaneous mental task while walking.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Medial and Lateral Center of Mass Displacement Dual Task	4.73 deg2 Standard Deviation 0.65	3.99 deg2 Standard Deviation 0.3

SECONDARY outcome

Timeframe: both footwear conditions up to 30 minutes

Gait speed variability (estimated using coefficient and variation of stride velocity) Single task means walking without a simultaneous mental task.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Gait Speed Variability Single Task	6.8 percentage of gait Standard Deviation 2.3	5.5 percentage of gait Standard Deviation 2.1

SECONDARY outcome

Timeframe: Both footwear conditions up to thirty minutes

Gait speed variability (estimated using coefficient and variation of stride velocity) Dual task used a simultaneous mental task while walking.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Gait Speed Variability Dual Task	7.45 percentage of gait Standard Deviation 2.69	5.08 percentage of gait Standard Deviation 0.97

OTHER_PRE_SPECIFIED outcome

Timeframe: during each foot wear condition up to 30 minutes

Stride velocity steady state gait single task. Single task means walking without a simultaneous mental task.

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Stride Velocity - Single Task	1.08 meters/second Standard Deviation 0.005	1.10 meters/second Standard Deviation 0.004

OTHER_PRE_SPECIFIED outcome

Timeframe: at baseline, this is a single visit study expected to last one hour

Sudomotor function will be measured by electrical sweat conductance (ESC), as expressed in microSiemens (µS).

Outcome measures

Outcome measures
Measure	Standard Innersole n=27 Participants The industry standard diabetic innersole will be used as the active comparator Standard innersole	Diabetic Foot Orthotic n=27 Participants The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
Sudomotor Function	70.15 µS Standard Deviation 11.43	70.15 µS Standard Deviation 11.43

Adverse Events

Standard Innersole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetic Foot Orthotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Wrobel, DPM, MS

University of Michigan

Phone: 734-647-4940

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place