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Diabetic PolyneuropathyNCT03687840

Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Lower Extremity Burn Injury.

A study testing gait analysis in people with Diabetic Polyneuropathy and Foot Injuries, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetic Polyneuropathy, Foot Injuries
What is being tested?
gait analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesTurkey (Türkiye)
Study dates
14 Feb 2017to 11 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Ankara Training and Research Hospital

    Ankara, Cankaya, 06100

  • Numune Training and Research Hospital

    Ankara, Cankaya, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Polyneuropathic Individuals With Lower Extremity Burn Injury

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.

Read the detailed description

Diabetic polyneuropathy, a frequent complication of diabetes, is used to describe sensory, motor and autonomic nerve damage caused by metabolic and micro vessel alterations due to hyperglycaemia. The signs and symptoms of diabetic polyneuropathy vary according to the type of nerve fiber affected. The involvement of the small nerve fibers results in deterioration of the pain and temperature perception, while the impairing of large nerve fibers result in decrease of touch and proprioception sensations. Due to the sensory loss, accidental foot injuries may develop in patients with diabetic polyneuropathy. While the feet constitute a small percentage (3.5%) of the total body surface area, burn injuries of them in patients with diabetic polyneuropathy can cause significant effects on quality of life because impaired wound healing process in diabetics may cause risk of prolonged bed rest and hospitalization period, and increased early and late complications. Therefore, it has an important effects on daily living activities because it causes inadequacies in gait and balance activities due to the negative effects on mobility and weight bearing functions. In studies that examining changes in gait parameters in other diabetic foot complications such as sensory loss, ulceration, and amputation as secondary to diabetic polyneuropathy have shown that these individuals acquire a protective adaptive gait strategies that allow for more controlled gait in the present of proprioceptive deficits such as slower gait speed, smaller step length and in particular increased opposite foot off time in order to shift body weight from injured limb to unaffected side. There's no studies have yet been conducted to investigating of changes in gait parameters in patients who have diabetic polyneuropathy-related lower extremity burn injury. The aim of this case-control study is to examine whether similar gait strategies have been gained in this group of patients, as indicated in the results of previous studies demonstrating protective adaptive gait strategies that adopt under the presence of other diabetic foot complications due to diabetic polyneuropathy.

Being tested
gait analysis
Keywords
Diabetic Polyneuropathy, Lower Extremity Burn Injury, Spatio-Temporal Parameters of Gait, Gait Symmetry
Medical subject headings
Diabetic Neuropathies, Foot Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gait analysisDiagnostic test

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

Study groups in NCT03687840
Study groupRoleWhat they receive
Study GroupOtherSpatio-Temporal gait analysis of subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy.
Receives: Diagnostic Test: gait analysis
Control GroupOtherSpatio-Temporal gait analysis of subjects with only diabetic polyneuropathy.
Receives: Diagnostic Test: gait analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 week

Secondary outcomes (9)

  1. Stride Length

    It is measured on the line of progression between the heel points of two consecutive footprints of the same foot (left to left, right to right). The unit of measure is centimeters.

    Measured: 1 week

  2. Step Width

    It is measured from the midline midpoint of the current footprint to the midline midpoint of the previous footprint on the opposite foot.The unit of measure is centimeters.

    Measured: 1 week

  3. Foot Progression Angle

    It is the angle between the line of progression and the midline of the footprint. This angle is zero if the geometric mid- line of the footprint is parallel to the line of progression; positive, toe-out, when the mid-line of the footprint is outside the line of progression and negative, toe-in, when inside the line of progression. The unit of measure is degrees.

    Measured: 1 week

  4. Speed

    It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)

    Measured: 1 week

  5. Cadence

    The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.

    Measured: 1 week

  6. Percentage of Double Support

    It is the amount of time that a person spends with both feet on the ground during one gait cycle. It is presented as a percentage of the gait cycle time (% gait cycle). The percentage of time spent in double support decreases as the speed of walking increases.

    Measured: 1 week

  7. Percentage of Stance

    The stance phase is the weight bearing portion of each gait cycle. It is initiated by heel contact and ends with toe off of the same foot. It is the time elapsed between the first contact and the last contact of two consecutive footfalls on the same foot. It is also presented as a percentage of the gait cycle time (% gait cycle)

    Measured: 1 week

  8. Percentage of Swing

    It is initiated with toe off and ends with heel strike. It is the time elapsed between the last contact of the current footfall to the first contact of the next footfall on the same foot. It is expressed in seconds (sec) and it is also presented as a percent of the gait cycle (% gait cycle) of the same foot. The Swing Time is equal to the Single Support time of the opposite foot.

    Measured: 1 week

  9. Symmetry Index

    It's calculated in order to evaluate symmetry and bilateral coordination of gait. The Symmetry Index and Symmetry Angle are interpreted as a complete symmetry if the result is 0. Evaluation of asymmetries observed in the spatio-temporal characteristics, a deviation of at least 10% from the 0 value for exact symmetry.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2018
  2. Study start14 Feb 2017
  3. Primary completion11 Feb 2018
  4. Study completion11 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03687840
Sponsor's protocol ID
GO 17/07
Status last verified
Sep 2018
First submitted
22 Aug 2018
Last updated
27 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.

Publications

  • 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.

    PubMed 24656951

Questions about this trial

What is this clinical trial studying?

A study testing gait analysis in people with Diabetic Polyneuropathy and Foot Injuries, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step Length (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03687840, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.

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