Trial record 3 of 2133 for:    foot

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Wrobel, DPM, MS, University of Michigan
ClinicalTrials.gov Identifier:
NCT01844479
First received: April 12, 2013
Last updated: July 1, 2016
Last verified: July 2016
  Purpose
In this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes. The second objective is to study twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for changes in spatial temporal gait including gait initiation, risk of falling, static and dynamic balance, and plantar temperature response to walking and consecutive plantar stress in both footwear conditions.

Condition Intervention
Diabetic Foot Ulcer
Diabetic Foot
Device: diabetic foot orthotic
Other: Standard innersole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-material, Layer, and Density Insoles for a Patient-specific Approach to Shear and Pressure Reduction in the Treatment and Prevention of Diabetes-related Foot Ulcer

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking [ Time Frame: baseline and after 200 steps in each condition, this is a single visit study expected to last one hour ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Gait Initation - Single Task [ Time Frame: during each foot wear condition up to 30 minutes ] [ Designated as safety issue: Yes ]
    The number of steps taken to reach steady state walking under single task. Single task means walking without a simultaneous mental task.

  • Gait Initiation - Dual Task [ Time Frame: during each foot wear condition up to 30 minutes ] [ Designated as safety issue: Yes ]
    The number of steps taken to reach steady state walking under dual task. Dual task used a simultaneous mental task while walking.

  • Stride Velocity - Dual Task [ Time Frame: during each foot wear condition up to 30 minutes ] [ Designated as safety issue: Yes ]
    Stride velocity during steady state dual task. Dual task used a simultaneous mental task while walking.

  • Double Support Time Single Task [ Time Frame: during each foot where condition up to 30 minutes ] [ Designated as safety issue: Yes ]
    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.

  • Double Support Time Dual Task Gait Initiation [ Time Frame: during each foot where condition up to 30 minutes ] [ Designated as safety issue: Yes ]
    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.

  • Medial and Lateral Center of Mass Displacement Single Task [ Time Frame: under each foot where condition up to 30 minutes ] [ Designated as safety issue: Yes ]
    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.

  • Medial and Lateral Center of Mass Displacement Dual Task [ Time Frame: both footwear conditions up to 30 minutes ] [ Designated as safety issue: Yes ]
    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.

  • Gait Speed Variability Single Task [ Time Frame: both footwear conditions up to 30 minutes ] [ Designated as safety issue: Yes ]
    Gait speed variability (estimated using coefficient and variation of stride velocity) Single task means walking without a simultaneous mental task.

  • Gait Speed Variability Dual Task [ Time Frame: Both footwear conditions up to thirty minutes ] [ Designated as safety issue: Yes ]
    Gait speed variability (estimated using coefficient and variation of stride velocity) Dual task used a simultaneous mental task while walking.


Other Outcome Measures:
  • Stride Velocity - Single Task [ Time Frame: during each foot wear condition up to 30 minutes ] [ Designated as safety issue: No ]
    Stride velocity steady state gait single task. Single task means walking without a simultaneous mental task.

  • Sudomotor Function [ Time Frame: at baseline, this is a single visit study expected to last one hour ] [ Designated as safety issue: No ]
    Sudomotor function will be measured by electrical sweat conductance (ESC), as expressed in microSiemens (µS).


Enrollment: 27
Study Start Date: December 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard innersole

Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.

The industry standard diabetic innersole will be used as the active comparator

Other: Standard innersole
Experimental: 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.
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 Name: shear reducing innersole

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  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will be included if they have diabetes and have been referred for diabetic shoes. They will also be insensate with pre-ulcerative plantar callus or previous plantar foot ulcer.

Exclusion Criteria:

  • Patients will be excluded if they are unable to independently walk 100 feet, lower extremity prosthesis user, have active cellulitis, foot ulcer, or Charcot foot.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844479

Locations
United States, Michigan
Michigan Orthotics and Prosthetics
Ann Arbor, Michigan, United States, 48104-6768
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: James Wrobel, DPM, MS UMHS
  More Information

Publications:
Responsible Party: James Wrobel, DPM, MS, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01844479     History of Changes
Other Study ID Numbers: HUM00059211  HUM00059211 
Study First Received: April 12, 2013
Results First Received: June 12, 2015
Last Updated: July 1, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
diabetic foot ulcer
diabetic foot

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Foot Diseases
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on August 25, 2016