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

NACompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Diabetic Foot UlcerDiabetic Foot
Interventions
DEVICE

diabetic foot orthotic

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.

OTHER

Standard innersole

Trial Locations (1)

48104-6768

Michigan Orthotics and Prosthetics, Ann Arbor

All Listed Sponsors
lead

University of Michigan

OTHER

NCT01844479 - Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer | Biotech Hunter | Biotech Hunter