Ingrown NailTOCONNCT05214586
Conservative Treatment of Ingrown Toenail
A study testing Follow up of the clinical stage in people with Ingrown Nail and Nails, Abnormal, run by Universidad de Extremadura at 1 site in Spain.
Trial summary
Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for consultation in podiatry clinics. In the initial stages of the pathology, conservative treatments are the first choice of therapy. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Ingrown Nail, Nails, Abnormal
- What is being tested?
- Follow up of the clinical stage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2022to 30 May 2022
- Phase
- Interventional
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ingrown toenail in stage I or IIa (Mozena Classification)
Who cannot join
- Patients not allowed for clinical follow-up of the evolution of the pathology.
- Patients presented with deforming pathologies
- Pattens had been surgically operated for ingrown toenail
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conservative Treatment of Ingrown Toenail in Stages I or IIa
Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for consultation in podiatry clinics. In the initial stages of the pathology, conservative treatments are the first choice of therapy. The aim was therefore, to analyze and compare the efficacy of the technique of nail re-education with gauze bandage and nail remodelling for the conservative treatment of onychocryptosis in stage I and IIA, A prospective, longitudinal, randomised clinical trial-type analytical study is proposed. A sample of 20 subjects with stage I and IIA onychocryptosis will be selected. Of these, 10 cases were part of the gauze bandage nail re-education group and the remaining 10 cases were part of the nail remodelling group.
- Conditions
- Ingrown Nail, Nails, Abnormal
- Being tested
- Follow up of the clinical stage
- Keywords
- Ingrown toenail, Conservative treatment, Recurrence, Podiatry, Nail remodelling
- Medical subject headings
- Nails, Ingrown, Nails, Malformed, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow up of the clinical stageProcedure or surgery
Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured
| Study group | Role | What they receive |
|---|---|---|
| Spiculotomy and application of a Gel Nail | Experimental | A nail spicule removal technique will be performed of the edge or nail edges affected by ingrown toenail. After, a gel nail will be applied to remodeling the nail apparatus and avoid damage of the nail in the lateral fold. Receives: Procedure: Follow up of the clinical stage |
| Spiculotomy and Nail Re-education with Gauze Bandage | Active comparator | A nail spicule removal technique will be performed and a cord of gauze bandage between the nail channel and the sheet will be applied. This technique consists in the removal of the portion of the nail sheet that causes ingrown toenail in order to release the soft parts. Receives: Procedure: Follow up of the clinical stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of the disease
Recurrence is defined as a return of the previous symptoms, regrowth of the nail edge, or patient dissatisfaction with the clinical outcome.
Measured: 3 months
Secondary outcomes (4)
Reported pain
Visual analogue scale of pain (0-10)
Measured: Every clinic visit of the patient until 3 months
Infection
Presence of infection symptoms as oozing or built up fluid around the affected area, bleeding, foul smell, overgrowth tissues around the edges of the toenail or abscess filled with puss.
Measured: Every clinic visit of the patient until 3 months
Swelling
Presence of swelling symptoms as pain, redness and hardardening around the affected toenail.
Measured: Every clinic visit of the patient until 3 months
Patient satisfaction
Patient satisfaction survey (0-10)
Measured: Every clinic visit of the patient until 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Feb 2022
- Primary completion30 Apr 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ingrown NailStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Alfonso Martínez Nova, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214586
- Sponsor's protocol ID
- TOCON
- Acronym
- TOCON
- Status last verified
- May 2022
- First submitted
- 30 Dec 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Treatment of Ingrown Toenail in Stages I or IIa
- ClinicalTrials.gov ID
- NCT05214586
- Acronym / sponsor ID
- TOCON / TOCON
- Conditions
- Ingrown Nail, Nails, Abnormal
- Keywords
- Ingrown toenail, Conservative treatment, Recurrence, Podiatry, Nail remodelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 28 Jan 2022 (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.
Ingrown toenail has become one of the most prevalent onychopathies and a frequent reason for consultation in podiatry clinics. In the initial stages of the pathology, conservative treatments are the first choice of therapy. The aim was therefore, to analyze and compare the efficacy of the technique of nail re-education with gauze bandage and nail remodelling for the conservative treatment of onychocryptosis in stage I and IIA, A prospective, longitudinal, randomised clinical trial-type analytical study is proposed. A sample of 20 subjects with stage I and IIA onychocryptosis will be selected. Of these, 10 cases were part of the gauze bandage nail re-education group and the remaining 10 cases were part of the nail remodelling group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiculotomy and application of a Gel Nail | Experimental | Procedure: Follow up of the clinical stageA nail spicule removal technique will be performed of the edge or nail edges affected by ingrown toenail. After, a gel nail will be applied to remodeling the nail apparatus and avoid damage of the nail in the lateral fold. |
| Spiculotomy and Nail Re-education with Gauze Bandage | Active comparator | Procedure: Follow up of the clinical stageA nail spicule removal technique will be performed and a cord of gauze bandage between the nail channel and the sheet will be applied. This technique consists in the removal of the portion of the nail sheet that causes ingrown toenail in order to release the soft parts. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Ingrown toenail in stage I or IIa (Mozena Classification)
Key exclusion criteria (3 listed)
- Patients not allowed for clinical follow-up of the evolution of the pathology.
- Patients presented with deforming pathologies
- Pattens had been surgically operated for ingrown toenail
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 |
|---|---|---|
| Follow up of the clinical stagePain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured | Procedure or surgery | Spiculotomy and Nail Re-education with Gauze Bandage, Spiculotomy and application of a Gel Nail |
Primary outcome
Recurrence of the disease
Time frame: 3 months
Recurrence is defined as a return of the previous symptoms, regrowth of the nail edge, or patient dissatisfaction with the clinical outcome.
4 secondary outcomes
Reported pain
Time frame: Every clinic visit of the patient until 3 months
Infection
Time frame: Every clinic visit of the patient until 3 months
Swelling
Time frame: Every clinic visit of the patient until 3 months
Patient satisfaction
Time frame: Every clinic visit of the patient until 3 months
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 2 Jun 2022.
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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?
A study testing Follow up of the clinical stage in people with Ingrown Nail and Nails, Abnormal, run by Universidad de Extremadura at 1 site in Spain.
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 1 inclusion and 3 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 2 Jun 2022. 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 Spain. 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?
Recurrence of the disease (time frame: 3 months). 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 2 Jun 2022.