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

NCT01844479 | Completed Results

• 1 other identifier: HUM00059211
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer; Diabetic Foot

Keywords

diabetic foot ulcer; diabetic foot

Outcome Measures

Primary Outcomes (1)

• Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking

  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.

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

Secondary Outcomes (9)

• Gait Initation - Single Task

  during each foot wear condition up to 30 minutes

• Gait Initiation - Dual Task

  during each foot wear condition up to 30 minutes

• Stride Velocity - Dual Task

  during each foot wear condition up to 30 minutes

• Double Support Time Single Task

  during each foot where condition up to 30 minutes

• Double Support Time Dual Task Gait Initiation

  during each foot where condition up to 30 minutes

Other Outcomes (2)

• Stride Velocity - Single Task

  during each foot wear condition up to 30 minutes

• Sudomotor Function

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

Study Arms (2)

Standard innersole

ACTIVE COMPARATOR

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

Diabetic Foot Orthotic

EXPERIMENTAL

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

Interventions

diabetic foot orthotic DEVICE

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.

Also known as: shear reducing innersole

Diabetic Foot Orthotic

Standard innersole OTHER

Standard innersole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Orthotics and Prosthetics

Ann Arbor, Michigan, 48104-6768, United States

Location

Related Publications (2)

• Belmont B, Wang Y, Ammanath P, Wrobel JS, Shih A. An apparatus to quantify anteroposterior and mediolateral shear reduction in shoe insoles. J Diabetes Sci Technol. 2013 Mar 1;7(2):410-9. doi: 10.1177/193229681300700218.

  PMID: 23567000 RESULT

• Wrobel JS, Ammanath P, Le T, Luring C, Wensman J, Grewal GS, Najafi B, Pop-Busui R. A novel shear reduction insole effect on the thermal response to walking stress, balance, and gait. J Diabetes Sci Technol. 2014 Nov;8(6):1151-6. doi: 10.1177/1932296814546528. Epub 2014 Aug 7.

  PMID: 25107709 RESULT

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: James Wrobel, DPM, MS
• Organization: University of Michigan

jswrobel@med.umich.edu

734-647-4940

Study Officials

• James Wrobel, DPM, MS

  UMHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: May 1, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 6, 2016
• Results First Posted: July 20, 2016

Record last verified: 2016-08

Locations

US (1)