Evidence map›Paper›PMID 25107709›Full record

Trial reportJournal of diabetes science and technology2014

A novel shear reduction insole effect on the thermal response to walking stress, balance, and gait.

James S Wrobel, Peethambaran Ammanath, Tima Le, Christopher Luring, Jeffrey Wensman, Gurtej S Grewal, Bijan Najafi, Rodica Pop-Busui

Registry-linked trialOpen access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01844479 (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), which is not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01844479 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of MichiganRan2012 to 2014Enrolled27ConditionsDiabetic Foot Ulcer, Diabetic FootArmsdiabetic foot orthotic, Standard innersole
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 39 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

James S WrobelMetabolism, Endocrinology and Diabetes (MEND), University of Michigan, Ann Arbor, MI, USA jswrobel@med.umich.edu.
Peethambaran AmmanathMichigan Orthotics and Prosthetics Center, University of Michigan, Ann Arbor, MI, USA.
Tima LeMetabolism, Endocrinology and Diabetes (MEND), University of Michigan, Ann Arbor, MI, USA.
Christopher LuringMichigan Orthotics and Prosthetics Center, University of Michigan, Ann Arbor, MI, USA.
Jeffrey WensmanMichigan Orthotics and Prosthetics Center, University of Michigan, Ann Arbor, MI, USA.
Gurtej S GrewalUniversity of Arizona, Tucson, AZ, USA.
Bijan NajafiUniversity of Arizona, Tucson, AZ, USA.
Rodica Pop-BusuiMetabolism, Endocrinology and Diabetes (MEND), University of Michigan, Ann Arbor, MI, USA.
University of Michigan–Ann Arbor · USUniversity of Arizona · US

Funding

Regional Pilot And Feasibility Study Grants ProgramP30DK020572 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Mehboob A Hussain · 2013 to 2026
$24.3M
Research BaseP30DK092926 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MARY ELLEN MICHELE HEISLER, ADESUWA B OLOMU · 2011 to 2026
$10.0M
NIDDK NIH HHS P30 DK020572NIDDK NIH HHS P30DK020572NIDDK NIH HHS P30 DK092926
6 · The paper itself

Abstract

Shear stresses have been implicated in the formation of diabetes-related foot ulcers. The aim of this study was to evaluate the effect of a novel shear-reducing insole on the thermal response to walking, balance, and gait. Twenty-seven diabetes peripheral neuropathy patients were enrolled and asked to take 200 steps in both intervention and standard insoles. Thermal foot images of the feet were taken at baseline (1) following a 5-minute temperature acclimatization and (2) after walking. Testing order was randomized, and a 5-minute washout period was used between testing each insole condition. Sudomotor function was also assessed. Gait and balance were measured under single and dual task conditions using a validated body worn sensor system. The mean age was 65.1 years, height was 67.3 inches, weight was 218 pounds, and body mass index was 33.9, 48% were female, and 82% had type 2 diabetes. After walking in both insole conditions, foot temperatures increased significantly in standard insoles. The intervention insole significantly reduced forefoot and midfoot temperature increases (64.1%, P = .008; 48%, P = .046) compared to standard insoles. There were significant negative correlations with sudomotor function and baseline temperatures (r = .53-.57). The intervention demonstrated 10.4% less gait initiation double support time compared to standard insoles (P = .05). There were no differences in static balance measures. We found significantly lower forefoot and midfoot temperature increases following walking with shear-reducing insoles compared to standard insoles. We also found improvements in gait. These findings merit future study for the prevention of foot ulcer.

Indexed as

Foot OrthosesAgedBody TemperatureCross-Sectional StudiesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic FootDiabetic NeuropathiesFemaleGaitHumansMaleMiddle AgedPostural BalanceStress, MechanicalWalkingautonomic dysfunctionfootfoot biomechanicsfoot complicationsfoot wearorthoticsshear friction

Identifiers

PMID25107709
PMCPMC4455476
OpenAlexW2168722139

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.