NCT02220881

Brief Summary

The primary objective of this study is to investigate the effectiveness of mold making silicone toe separator on reducing the hallux valgus angle. In addition, this study aims to determine the compliance of mold making silicone toe separator, the change in pain level and, including, the satisfaction of the participants after using mold making silicone toe separator.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

1.6 years

First QC Date

January 8, 2014

Last Update Submit

August 18, 2014

Conditions

Hallux Valgus

Keywords

Hallux valgus, Mold making silicone toe separator, Toe separator

Outcome Measures

Primary Outcomes (2)

  • Change from baseline of degree of Hallux valgus angle at month 6 ans month 12

    Hallux valgus angle will be measured from the x-ray film taken in standing position with full weight bearing

    Baseline, month 6, month 12

  • Change from baseline of degree of intermetatarsal angle at month 6 ans month 12

    Intermetatarsal angle will be measured from the x-ray film taken in standing position with full weight bearing

    Baseline, month 6, month 12

Secondary Outcomes (1)

  • Change from baseline in pain score on 11-point Visual Analog Scale at month 3, month 6, month 9 and month 12

    Baseline, month 3, month 6, month 9 and month 12

Other Outcomes (1)

  • Compliance of using Mold Making Silicone Toe Separator

    Baseline, month 3, month 6, month 9 and month 12

Study Arms (2)

Mold making silicone toe separator

EXPERIMENTAL

The subject in experimental group will use mold making silicone toe separator everyday

Device: Mold making silicone toe separator

Observation

OTHER

This group will follow the physician instruction of care for the hallux valgus

Other: Observation

Interventions

Mold making silicone toe separatorDEVICE

Each subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use

Also known as: Toe separator
Mold making silicone toe separator
ObservationOTHER

The participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month.

Also known as: Control group
Observation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 18 years of age
  • Presence of hallux valgus deformity in moderate level, if the condition presents in both side, the one with greater angle will be selected
  • Never use hallux valgus strap or toes separator before

You may not qualify if:

  • Presence of hallux rigidus and hallux limitus
  • Presence of acute hallux inflammation
  • Experience the use hallux valgus strap or toes separator in a past year
  • Experience the allergy to silicone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Interventions

ObservationControl Groups

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative TechniquesEpidemiologic Research DesignEpidemiologic MethodsResearch Design

Central Study Contacts

Navaporn Chadchavalpanichaya, MD, C.Ped

CONTACT

drnavaporn@gmail.com

Sirirat Sengiad, BSc, MA

CONTACT

siriratseng@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistance Professor

Study Record Dates

First Submitted

January 8, 2014

First Posted

August 20, 2014

Study Start

November 1, 2013

Primary Completion

June 1, 2015

Study Completion

May 1, 2016

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

TH(1)