NCT05713175

Brief Summary

The goal of this clinical trial is to compare the effectiveness of two conservative orthopedic treatments in propulsive metatarsalgia. The main question it aims to answer are:

  • To compare the effectiveness of treatments on foot pain and functionality in subjects diagnosed with propulsive metatarsalgia.
  • To determinate the influence of clinical and radiographical characteristics in pain improvement. Participants will wear the treatment for 3 months . Researchers will compare polypropylene and EVA insoles and Fixtoe Device® to see if a foot pain improvement is achieved.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

October 5, 2022

Last Update Submit

February 1, 2023

Conditions

MetatarsalgiaTreatmentFootFoot DiseasesOrthopedic DisorderSubluxation of Toe JointToe Joint Deformity

Keywords

MetatarsalgiaForefootFoot DiseasesTreatment

Outcome Measures

Primary Outcomes (2)

  • Foot Pain

    Foot Pain measured using a 11-point VAS score. 0 is the lower (better) value and 10 is the higher (worst) value.

    Up to 20 weeks.

  • Foot Pain and Disability

    Measured using the Foot Function Index (FFI-Sp) questionnaire (Spanish version). Higher values mean worse outcome and lower values mean better outcome.

    Up to 20 weeks.

Secondary Outcomes (35)

  • Demographic data: Age.

    Day 1.

  • Demographic data: Gender

    Day 1.

  • Demographic data: Wheight

    Day 1.

  • Demographic data: Height

    Day 1.

  • Demographic data: Body Mass Index (BMI)

    Day 1.

  • +30 more secondary outcomes

Study Arms (3)

EVA plantar orthosis

ACTIVE COMPARATOR

Treatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.

Device: EVA plantar orthosis

Polypropylene plantar orthosis

ACTIVE COMPARATOR

Treatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique.

Device: Polypropylene plantar orthosis

Fixtoe device

ACTIVE COMPARATOR

Fixtoe device, simulating the metatarsophalangeal joint stabilization tape technique . Worn for one month, prior to definitive treatment.

Device: EVA plantar orthosisDevice: Polypropylene plantar orthosisDevice: Fixtoe device

Interventions

EVA plantar orthosisDEVICE

Treatment consisting of a personalized plantar orthosis fabricated in 45º shore A hardness Ethyl Vinyl Acetate (EVA), which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.

EVA plantar orthosisFixtoe device
Polypropylene plantar orthosisDEVICE

Treatment consisting of a personalized plantar orthosis fabricated in 4mm polypropylene, which incorporates a 4mm heel rise and metatarsal dome placed proximal to the 2nd-3rd-4th metatarsal heads. No modifications applied to the patients' medial longitudinal arch.Orthosis fabricated following the inverted orthotic technique.

Fixtoe devicePolypropylene plantar orthosis
Fixtoe deviceDEVICE

Fixtoe Device, simulating the metatarsophalangeal stabilization tape technique is worn for one month, prior to definitive treatment consisting of a personalized plantar orthosis.

Fixtoe device

Eligibility Criteria

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

You may qualify if:

  • Mechanical pain in the 2nd or 3rd metatarsophalangeal joint (MTPJ)
  • Positive Laschman's drawer test in 2nd or 3rd MTPJ. (CITA)
  • Physical exploration revealing pain upon the palpation in plantar plate ( when cranial-caudal pressure was directly applied in the plantar aspect of the 2nd or 3rd MTPJ). (CITA)
  • Availability of dorsal-plantar and lateral wheightbearing radiography of the affected foot.

You may not qualify if:

  • Subjects with at least one of the following were excluded.
  • Deformity of the 2nr or 3rd metatarsal head (MTH) (Freiberg's disease)
  • Morton's neuroma and/or neuritic symptomatlogy y referred.
  • Rigid claw or hammer toe (positive Kelikian test) whithin radiographic dislocation of 2nd or 3rd MTPJ. (CITA)
  • Dermatological lesión plantar to 2nd or 3rd MTPJ (intractable plantar keratosis (IPK), foot ulcer, plantar wart, etc.)
  • Neurological, methabolical, vascular or rheumatological not-controlled systemic disease with potential manifestations in foot and ankle.
  • Previous history of foot or ankle surgery entailing limitations in mobility and/or alterations of the metatarsal parabola.
  • Previous history of foot or ankle fracture
  • Morpho-functional alteration of the lower limbs: clinical asymmetry greater than 10 mm and presence of asymmetric genu varus or valgus.
  • Alterations of the cognitive state preventing to understand the objective of the study and guidelines to follow for their participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Universitaria de Podología Complutense University Madrid

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

MetatarsalgiaFoot DiseasesMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Joint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ángel M Orejana-García, PhD

    Complutense University Madrid

    STUDY DIRECTOR

  • Raúl J Molines-Barroso, PhD

    Complutense University Madrid

    STUDY DIRECTOR

  • José Luis Lázaro-Martínez, PhD

    Complutense University Madrid

    STUDY DIRECTOR

  • Maria Ruiz-Ramos, MSc

    Complutense University Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant understands he is being part of a clinical trial but unknowns the treatment group he has been allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Groups Open Randomised Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2022

First Posted

February 6, 2023

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 6, 2023

Record last verified: 2023-01

Locations

ES(1)