NCT03717233

Brief Summary

Study will evaluate the use of lower-limb assistive exo-skeletons worn on the ankle and foot. Participants will wear the exo-skeletons and walk in a safe environment. Measurements will be taken to determine how the exo-skeletons affect the pressure on the feet of people with diabetic foot ulcer and how they walk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2019

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

October 22, 2018

Last Update Submit

February 27, 2020

Conditions

Diabetic Foot UlcerDiabetic Foot Ulcer Associated With Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Forefoot plantar pressure

    Measurements of the force and pressure on the bottom of the front of the foot

    30 minutes

Secondary Outcomes (1)

  • Measures of fall risk

    30 minutes

Study Arms (1)

Primary Arm

EXPERIMENTAL

Participants will be used as their own controls. Participants will be evaluated using exo-skeletons with non-motorized spring elements in parallel to the Achilles tendon. Up to 5 different levels of spring force will be evaluated to evaluate the impact upon plantar pressure and measures of fall risk.

Device: Exoskeleton

Interventions

ExoskeletonDEVICE

Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot

Primary Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-reported history of diabetic foot ulcer

You may not qualify if:

  • Unable to continuously ambulate/walk ≥ 40 feet without an assistive device, such as a cane or walker
  • Signs/symptoms of an infected foot lesion/ulcer as determined by a basic foot exam
  • Trans-metatarsal foot amputation or more significant amputation.
  • Symptomatic for signs/symptoms of cardiovascular disease as determined from interpretation of the 2017 PAR-Q+ (predicated on participant responses of "yes" indicating symptomatic/unstable medical conditions to page 2 and page 3 of the 2017 PAR-Q)
  • Participants will be excluded from this study if they demonstrate pre-participation, or chronic, signs/symptoms of hypoglycemia: Confusion, unusual headache, unusual visual disturbances, self-reported mental dullness, shakiness, self-reported weakness, abnormal sweating, undue nervousness/anxiety, and/or tingling of the mouth, toes, and/or fingers or if they answer yes to question 5b and 5c of the 2017 PAR-Q+ .
  • Participants will be temporarily excluded from this study if they are symptomatic for acute illness such as cold or fever. If the participant is symptomatic for acute illness such as cold or fever, participation will be reconsidered upon illness resolution.
  • If participants answer yes to question 4a of the 2017 PAR-Q+ and if they demonstrate pre-study participation resting blood pressure \< 90/60 mmHg and \>140/90 mmHg .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rancho Los Amigos

Los Angeles, California, 90242, United States

Location

Southern CT State University

New Haven, Connecticut, 06515, United States

Location

Related Publications (1)

  • Roser MC, Canavan PK, Najafi B, Cooper Watchman M, Vaishnav K, Armstrong DG. Novel In-Shoe Exoskeleton for Offloading of Forefoot Pressure for Individuals With Diabetic Foot Pathology. J Diabetes Sci Technol. 2017 Sep;11(5):874-882. doi: 10.1177/1932296817726349.

    PMID: 28859516BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Participants will be evaluated as their own controls.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

October 18, 2018

Primary Completion

October 17, 2019

Study Completion

October 17, 2019

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)