Evidence map›Paper›PMID 28859516›Full record

Trial reportJournal of diabetes science and technology2017

Novel In-Shoe Exoskeleton for Offloading of Forefoot Pressure for Individuals With Diabetic Foot Pathology.

Mark C Roser, Paul K Canavan, Bijan Najafi, Marcy Cooper Watchman, Kairavi Vaishnav, David G Armstrong

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

Trial report in Journal of diabetes science and technology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03717233 (Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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.

NCT03717233 nacompletednot on this mapstarted 2018, after this paper: background citation

Assistive ExoSkeleton & ExoTendon Platform to Enable Wearable Rehabilitation Robotics

TypeinterventionalSponsorResults Group LLCRan2018 to 2019Enrolled40ConditionsDiabetic Foot Ulcer, Diabetic Foot Ulcer Associated With Type II Diabetes MellitusArmsExoskeleton
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Prospective Cohort Validation Study of a Novel Foot Offloading Device.Plastic and reconstructive surgery. Global open · 2021
    Article
  4. Review
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

6 authors at 3 institutions in 1 country.

Mark C Roser1 Results Group, LLC, Tolland, CT, USA.
Paul K Canavan1 Results Group, LLC, Tolland, CT, USA.
Bijan Najafi3 Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
Marcy Cooper Watchman3 Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
Kairavi Vaishnav3 Southwestern Academic Limb Salvage Alliance (SALSA), Department of Surgery, University of Arizona, Tucson, AZ, USA.
David G Armstrong5 Southwestern Academic Limb Salvage Alliance (SALSA), Keck School of Medicine, University of Southern California, CA, USA.
University of Arizona · USUMass Memorial Medical Center · USUniversity of Southern California · US

Funding

ACL HHS 90BI0028
6 · The paper itself

Abstract

introductionInfected diabetic foot ulcers are the leading cause of lower limb amputation. This study evaluated the ability of in-shoe exoskeletons to redirect forces outside of body and through an exoskeleton as an effective means of offloading plantar pressure, the major contributing factor of ulceration.

methodsWe compared pressure in the forefoot and hind-foot of participants (n = 5) shod with novel exoskeleton footwear. Plantar pressure readings were taken during a 6-m walk at participant's self-selected speed, and five strides were averaged. Results were taken with Achilles exotendon springs disengaged as a baseline, followed by measurements taken with the springs engaged.

resultsWhen springs were engaged, all participants demonstrated a decrease in forefoot pressure, averaging a 22% reduction ( P < .050). Patient feedback was universally positive, preferring the exotendon springs to be engaged and active.

conclusionsOffloading is standard of care for reducing harmful plantar pressure, which may lead to foot ulcers. However, current offloading modalities are limited and have issues. This proof-of-concept study proposed a novel offloading approach based on an exoskeleton solution. Results suggest that when the novel exoskeletons were deployed in footwear and exotendon springs engaged, force was successfully transferred from the lower leg through the exoskeleton-enabled shoe to ground, reducing load on the forefoot. The results need to be confirmed in a larger sample. Another study is warranted to examine the effectiveness of this offloading to prevent diabetic foot ulcer, while minimizing gait alteration in daily physical activities.

Indexed as

Exoskeleton DeviceShoesAdultDiabetic FootFemaleFootHumansMaleMiddle AgedPressurediabetic foot ulcerexoskeletonoffloadingpassive wearable robotwound healing

Identifiers

PMID28859516
PMCPMC5951007
OpenAlexW2753803479

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.