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Completed

NCT Number: NCT03843177

Association of Ingrown Toenails With Flat Foot, Hallux Abducto Valgus and Hallux Limitus

This study will have implications for any healthcare professionals who routinely manage ingrown toenails. Although different conservative and surgical treatment have been suggested, the recurrent rate is still high ranging from 20% to 30%. The objective of this study was to investigate the association of ingrown toenail (IGTN) with flat foot, hallux abducto valgus (HAV) and hallux limitus (HL), and to provide directions for addressing biomechanical risk factors in the prevention of recurrent ingrown toenails. This was the first study to investigate the association of IGTN with flat foot, and the first study in Chinese community to investigate the association of IGTN with HAV or HL.

Participants with ingrown toenails (IGTN) were recruited to this study and compared with control participants with no history of ingrown toenails.

The inclusion criteria for the IGTN group were: (1) history of ingrown toenails on hallux within 1 year and (2) dorso-plantar standing view of foot x-ray taken or to be taken.

The exclusion criteria for the IGTN group were: (1) paediatrics (Age<18), (2) pincer nails / fungal nails, (3) prior existence of osteoarticular surgery in the foot, (4) severe trauma that changes foot morphology, (5) uncontrolled systemic disease, (6) pre-existing neurological diseases and (7) lower limb paralysis or paresis.

The inclusion criterion for the control group was dorso-plantar standing view of foot x-ray taken or to be taken.

The exclusion criteria for the control group were: (1) all the exclusion criteria of IGTN group, (2) history of IGTN in his or her lifetime and (3) flatfoot / first metatarsophalangeal joint pathology as the chief complaint.

The symptomatic foot (or the more symptomatic foot in the case of bilateral involvement) in the IGTN group was examined. The left or right foot of the control group was randomly selected such that the ratio of the left or the right foot in the IGTN and control group was the same.

Their foot posture index-6 components, Staheli's index, radiological hallux valgus angle and active maximum dorsiflexion of the first metatarsophalangeal joint on weight-bearing were measured and compared.

For dependent variables with significant correlation, a one-way multivariate analysis of variance (MANOVA) was carried out to determine if there was a significant difference on the combined dependent variables. For dependent variables without significant correlation, separate independent sample t-tests / welch t-tests were performed.

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Key information

Conditions

Ingrown Toe Nail Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Flat Foot Flatfoot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Foot Injuries Hallux Abductovalgus Hallux Limitus Hallux Valgus Joint Diseases Leg Injuries Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Nail Diseases Nails, Ingrown Skin Diseases Skin and Connective Tissue Diseases Talipes Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong

About this study

Precautions were taken to ensure consistency in measurement. To standardize the bisection techniques in measuring radiological hallux valgus angle, this study followed the recommendation from the American Orthopaedic Foot & Ankle Society. The longitudinal axis of the first metatarsal and that of the first proximal phalanx were formed respectively by 2 reference points marked on each of the two bones. The reference points on the first proximal phalanx were 1/2 to 1 cm proximal or distal to the articular surface while the reference points on the first metatarsal were 1 to 2 cm proximal or distal to the articular surface.

The active maximum dorsiflexion of the first metatarsophalangeal joint was measured with goniometer on weight-bearing. The bisection was carried out under a weight-bearing condition to avoid error due to soft-tissue movement when participants changed from a non weight-bearing position to a weight-bearing position.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for the IGTN group:

  • history of ingrown toenails on hallux within 1 year
  • dorso-plantar standing view of foot x-ray taken or to be taken

Exclusion criteria

for the IGTN group:

  • paediatrics (Age<18)
  • pincer nails / fungal nails
  • prior existence of osteoarticular surgery in the foot
  • severe trauma that changes foot morphology
  • uncontrolled systemic disease
  • pre-existing neurological diseases
  • lower limb paralysis or paresis

Inclusion criterion for the control group:

  • dorso-plantar standing view of foot x-ray taken or to be taken

Exclusion criteria

for the control group:

  • all the exclusion criteria of IGTN group
  • history of IGTN in his or her lifetime
  • flatfoot / first metatarsophalangeal joint pathology as the chief complaint

Treatment and study plan

No intervention

Other

No intervention will be performed. Only assessment will be done.

Primary outcomes

  1. Foot Posture Index-6 components

    Time frame: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

    • Clinical assessment for flat foot
    • Normal: 0 to +5
    • Pronated: +5 to +9 ; Highly pronated: +10 or above
    • Supinated: -1 to -4; Highly supinated: -5 to -12

  2. Staheli's Index

    Time frame: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

    • It provides a measurement of flat foot on footprint.
    • The Staheli's index increases as the foot becomes more pronated and is closer to zero as the foot becomes more supinated.

  3. radiological Hallux Valgus Angle

    Time frame: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

    • Radiological measurement for hallux abducto valgus
    • Normal: <15º

  4. Active maximum dorsiflexion of the first metatarsophalangeal joint on weight bearing

    Time frame: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group

    Clinical measurement with goniometer for hallux limitus

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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