N/A
N=27
Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related Foot Ulcer
Diabetic Foot Ulcer · Diabetic Foot
Bottom Line
View on ClinicalTrials.gov: NCT01844479 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking — 0.758; 0.272 Absolute change in temperature degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- diabetic foot orthotic (Device); Standard innersole (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking |
0.758; 0.272 | — |
| SECONDARY Gait Initation - Single Task |
4.53; 4.32 | — |
| SECONDARY Gait Initiation - Dual Task |
3.58; 3.42 | — |
| SECONDARY Stride Velocity - Dual Task |
1.01; 1.00 | — |
| SECONDARY Double Support Time Single Task |
31.6; 28.3 | — |
| SECONDARY Double Support Time Dual Task Gait Initiation |
31.5; 29.8 | — |
| SECONDARY Medial and Lateral Center of Mass Displacement Single Task |
4.60; 4.61 | — |
| SECONDARY Medial and Lateral Center of Mass Displacement Dual Task |
4.73; 3.99 | — |
| SECONDARY Gait Speed Variability Single Task |
6.8; 5.5 | — |
| SECONDARY Gait Speed Variability Dual Task |
7.45; 5.08 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01844479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.