Ingrown Toe NailNCT03843177
Association of Ingrown Toenails With Flat Foot, Hallux Abducto Valgus and Hallux Limitus
An observational study of Ingrown Toe Nail and Flat Foot, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ingrown Toe Nail, Flat Foot, Hallux Abductovalgus
- How many people
- 41 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Mar 2018to 27 Apr 2018
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending the Orthopaedic out-patient clinic at Prince of Wales Hospital in Hong Kong
Who may be able to join
- history of ingrown toenails on hallux within 1 year
- dorso-plantar standing view of foot x-ray taken or to be taken
- dorso-plantar standing view of foot x-ray taken or to be taken
Who cannot join
- 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
Show all 10Show fewer
- lower limb paralysis or paresis
- all the exclusion criteria of IGTN group
- history of IGTN in his or her lifetime
- flatfoot / first metatarsophalangeal joint pathology as the chief complaint
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Ingrown Toe Nail, Flat Foot, Hallux Abductovalgus, Hallux Limitus
- Being tested
- No intervention
- Medical subject headings
- Nails, Ingrown, Flatfoot, Hallux Valgus, Hallux Limitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be performed. Only assessment will be done.
| Study group | Role | What they receive |
|---|---|---|
| Ingrown toenails | Not described Receives: Other: No intervention | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Posture Index-6 components
- 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
Measured: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group
Staheli's Index
- 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.
Measured: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group
radiological Hallux Valgus Angle
- Radiological measurement for hallux abducto valgus
- Normal: <15º
Measured: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group
Active maximum dorsiflexion of the first metatarsophalangeal joint on weight bearing
Clinical measurement with goniometer for hallux limitus
Measured: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start14 Mar 2018
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrown Toe NailStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Him Shun KEI, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843177
- Sponsor's protocol ID
- 2017.637
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Ingrown Toenails With Flat Foot, Hallux Abducto Valgus and Hallux Limitus
- ClinicalTrials.gov ID
- NCT03843177
- Acronym / sponsor ID
- 2017.637
- Conditions
- Ingrown Toe Nail, Flat Foot, Hallux Abductovalgus, Hallux Limitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingrown toenails | – | Other: No intervention |
| Control | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the Orthopaedic out-patient clinic at Prince of Wales Hospital in Hong Kong
Key inclusion criteria (3 listed)
- history of ingrown toenails on hallux within 1 year
- dorso-plantar standing view of foot x-ray taken or to be taken
- dorso-plantar standing view of foot x-ray taken or to be taken
Key exclusion criteria (10 listed)
- paediatrics (Age<18)
- pincer nails / fungal nails
- prior existence of osteoarticular surgery in the foot
- severe trauma that changes foot morphology
- uncontrolled systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention will be performed. Only assessment will be done. | Other | Ingrown toenails |
Primary outcome
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
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Ingrown Toe Nail
Recruiting
Virtual Reality in Ingrown Toenail Surgery
Ingrown Toenail, Virtual Reality
Recruiting
Comparison of Two Surgical Methods (Winograd vs. Sleeve Method) in the Treatment of Ingrown Toenail.
Ingrown Toenail (Onychocryptosis)
Not yet recruiting
Virtual Reality, Music, and Education to Reduce Anxiety in Patients Undergoing Ingrown Toenail Surgery
Ingrown Toenail
Not yet recruiting
P : Ingrown Toenail Patient I : Bird Flap Surgery C : Noel Winograd Method O : Recurrence, Complications, Functional Outcome, Pain,
Ingrown Toenail
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ingrown Toe Nail and Flat Foot, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 10 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Foot Posture Index-6 components (time frame: throughout the study, within 1 year after ingrown toenails for the ingrown toenail group). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Feb 2019.