NCT04605900

Brief Summary

This study determines the effectiveness of plantar orthoses and custom-made orthopedic footwear in functional level and quality of life of persons with diabetes type 2 and diabetic peripheral neuropathy. This study is important due the loss of protective sensation, feet are vulnerable to minor trauma caused by plantar pressure as well as mechanical and thermal injuries. Thus, Plantar Orthoses become necessary to reduce PP and align the foot. Additionally, it is known that footwear is the most frequent cause of diabetic foot injury, since ulceration is frequently a consequence of the continuous trauma provoked by inadequate footwear. For a higher efficacy in the treatment of the foot, it is also necessary to use custom-made orthopedic footwear, indicated in the treatment of foot pathologies. The lack of studies that evaluate the impact of this treatment on clinical measures such as quality of life and functional level, led to the development of this study, comparing a standard treatment (standard footwear and plantar orthoses) with an optimal treatment suggested in diabetic foot guidelines (therapeutic footwear and plantar orthoses).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

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

March 13, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

October 15, 2020

Last Update Submit

October 28, 2020

Conditions

Diabetes Mellitus, Type 2Diabetic Peripheral Neuropathy

Keywords

Quality of lifePostural BalanceFunctionalityFoot OrthosesFootwear

Outcome Measures

Primary Outcomes (8)

  • Change the Quality of Life

    Significantly change any subscore or total score of Medical Outcomes Study 36-item Short-Form Health Survey instrument, that was use it to assess quality of life. Instrument scores can range between 0 - 100. Higher values mean better self-perception of quality of life.

    4 months

  • Change the Performance of Lower Extremity Functional Scale

    Change at least 9 points in Lower Extremity Functional Scale (minimum change for clinically relevant functional improvement). Instrument scores can range between 0 - 80. Higher values mean better functionality.

    4 months

  • Change the Functional Reach Test performance

    Significantly change the maximum distance (cm) attained in Functional Reach Test.

    4 months

  • Change the Unipedal Stance Test performance

    Change the time (s) in left and right unipedal stance.

    4 months

  • Change the Static Full Tandem Test performance

    Change the time (s) in full-tandem position.

    4 months

  • Change the Walking Full Tandem Test performance

    Achieve at least 10 steps in full-tandem.

    4 months

  • Change the Time Up and Go Test performance

    Change the time (s) in performing the Time Up and Go test.

    4 months

  • Change the 6 minutes walk test performance

    Change the distance (m) covered for 6 minutes of walking.

    4 months

Secondary Outcomes (24)

  • Change the Postural Stability (length displacement of Center of Pressure)

    4 months

  • Change the Postural Stability (displacement of Center of Pressure)

    4 months

  • Change the Postural Stability (Ellipse surface)

    4 months

  • Change the Postural Stability (Mean Speed of Center of Pressure)

    4 months

  • Change the Postural Stability (Standard deviation of Center of Pressure)

    4 months

  • +19 more secondary outcomes

Study Arms (2)

Standard Footwear (SF)

EXPERIMENTAL

Intervention: plantar orthoses, education on foot self-care and appropriate standard footwear.

Device: Standard FootwearDevice: Plantar OrthosesBehavioral: Education on foot self-care

Orthopedic Footwear (OF)

EXPERIMENTAL

Intervention: plantar orthoses, education on foot self-care and orthopedic footwear.

Device: Orthopedic FootwearDevice: Plantar OrthosesBehavioral: Education on foot self-care

Interventions

Orthopedic FootwearDEVICE

The orthopedic footwear used by the OF Group was manufactured by the company J. Andrade Ferreira Neves Lda. with materials suitable for the diabetic foot, as registered with INFARMED under registration ID 279515.

Orthopedic Footwear (OF)
Standard FootwearDEVICE

In the SF Group, it was recommended to use standard shoes more suitable for diabetic foot, with some specific characteristics, such as sports or walking shoes. The acquisition or not of a more suitable shoes by the participants was at the discretion of each individual.

Standard Footwear (SF)
Plantar OrthosesDEVICE

The plantar orthoses (PO) that both groups used for distribute of plantar loads was based on the principle of total contact. The confection material consisted in a liner of EVA shore 20º and polyurethane filling ELAX flexible (expandable) from OKM Química Ortopédica SL.

Orthopedic Footwear (OF)Standard Footwear (SF)
Education on foot self-careBEHAVIORAL

An information leaflet with foot care was delivered, with the aim of ensuring that participants were informed about the care they should continually take with their feet during the study period. This leaflet was created based on the guidelines of the "Associação Protetora dos Diabéticos" in Portugal.

Orthopedic Footwear (OF)Standard Footwear (SF)

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of type 2 DM;
  • Have at least 6 months from diagnosis of DM;
  • Presence of Diabetic Polyneuropathy;
  • No history of plantar orthoses and orthopedic footwear use.

You may not qualify if:

  • Active ulceration;
  • Severe osteoarticular deformities;
  • Presence of cognitive impairment;
  • Gait with technical devices;
  • Diagnosis of neurological pathology that can affect the gait pattern;
  • Diagnosis of another pathology that can negatively influence the study: depression, the presence of uncontrolled cardiovascular diseases and active cancer.
  • Surgical interventions on the spine and lower limbs, with less than 1 year of recovery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marta Botelho

Faro, Algarve, 8005-139, Portugal

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Marta Botelho, PhD

    Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A pre and post-test analysis was performed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellowship

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 28, 2020

Study Start

March 13, 2017

Primary Completion

January 4, 2018

Study Completion

May 21, 2018

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations

PT(1)