Trial record 3 of 1547 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: May 20, 2014
Last verified: May 2014
  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 analysis [ Time Frame: 200 steps each condition, this is a single visit study expected to last one hour ] [ Designated as safety issue: No ]
    Gait analysis, including gait initiation, gait speed, double support time, medial and lateral center of mass displacement, and inter-cycle variability under single and dual task conditions.


Other Outcome Measures:
  • Static balance [ Time Frame: in each condition, this is a single visit study expected to last one hour ] [ Designated as safety issue: No ]
    Static balance will also be measured in each footwear condition. Using the Romberg's test, we will also assess center of mass displacement and reciprocal hip and ankle motion under eyes open and closed conditions.

  • 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
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
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:
Belmont B, Wang Y, Ammanath P, Wrobel JS, Shih A. An apparatus to quantify anteroposterior and mediolateral shear reduction in shoe insoles, Journal of Diabetes Science and Technology. March 2013, 7(2); 410-419.

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
Last Updated: May 20, 2014
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
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 28, 2014