NCT03687840

Brief Summary

This study evaluated the spatio-temporal gait parameters and gait symmetry in individuals with lower extremity burn injury due to diabetic polyneuropathy. Study group consisted of 14 subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy and control group consisted of 14 subjects with only diabetic polyneuropathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

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

February 14, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

August 22, 2018

Last Update Submit

September 26, 2018

Conditions

Diabetic PolyneuropathyFoot Injuries

Keywords

Diabetic PolyneuropathyLower Extremity Burn InjurySpatio-Temporal Parameters of GaitGait Symmetry

Outcome Measures

Primary Outcomes (1)

  • Step Length

    It is measured along the length of the walkway, from the heel center of the current footprint to the heel center of the previous footprint on the opposite foot.The unit of measure is centimeters.

    1 week

Secondary Outcomes (9)

  • Stride Length

    1 week

  • Step Width

    1 week

  • Foot Progression Angle

    1 week

  • Speed

    1 week

  • Cadence

    1 week

  • +4 more secondary outcomes

Study Arms (2)

Study Group

OTHER

Spatio-Temporal gait analysis of subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy.

Diagnostic Test: gait analysis

Control Group

OTHER

Spatio-Temporal gait analysis of subjects with only diabetic polyneuropathy.

Diagnostic Test: gait analysis

Interventions

gait analysisDIAGNOSTIC_TEST

Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.

Control GroupStudy Group

Eligibility Criteria

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

You may qualify if:

  • Study group, include cases with a diagnosis of diabetic polyneuropathy and unilateral lower limb burn injury.
  • Control group consists of adults with a confirmed diagnosis of diabetic polyneuropathy without burn injury.

You may not qualify if:

  • presence of active ulcerations
  • presence of other diabetic morbidities (nephropathy, retinopathy, vestibulopathy)
  • orthopedic, musculoskeletal, neurological problems or previous surgical interventions that may affect the mobility and original gait dynamics except for diabetic polyneuropathy,
  • using of assistive devices
  • body mass index\> 40 kg/m²

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ankara Training and Research Hospital

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

Numune Training and Research Hospital

Ankara, Cankaya, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Jones LM, Coffey R, Khandelwal S, Atway S, Gordillo G, Murphy C, Fries JA, Dungan K. A clinician's guide to the treatment of foot burns occurring in diabetic patients. Burns. 2014 Dec;40(8):1696-701. doi: 10.1016/j.burns.2014.01.026. Epub 2014 Mar 20.

    PMID: 24656951BACKGROUND

MeSH Terms

Conditions

Diabetic NeuropathiesFoot Injuries

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

GaitPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisPhysical Functional PerformancePhysical FitnessHealthPopulation Characteristics

Study Officials

  • Melek M. ERDEM, PT, M.Sc.

    Tayyip Erdogan University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

  • Semra TOPUZ, Assoc. Prof.

    Hacettepe University

    STUDY DIRECTOR

  • Kemal KISMET, Assoc. Prof.

    Ankara Training and Research Hospital

    STUDY DIRECTOR

  • Gonul KOC, MD

    Ankara Training and Research Hospital

    STUDY CHAIR

  • Ahmet C. YASTI, Prof.

    Numune Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 22, 2018

First Posted

September 27, 2018

Study Start

February 14, 2017

Primary Completion

February 11, 2018

Study Completion

March 11, 2018

Last Updated

September 27, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data will be available within 6 months with completion of the result report.
Access Criteria
Requestors will be required to sign a Data Access Agreement.
More information

Locations

TU(2)