Pincer NailNCT02939521
Reconstructive Surgical Approach for Pincer Nail
A study testing Surgery in people with Pincer Nail, run by Clínica María del Mar Ruiz.
Trial summary
A prospective design that studies the effects of a new technique for the treatment of pincer nails. The technique consists of a flattening of the bone of the distal phalanx with a frontal skin lifting that is performed in patients with a pincer nail deformity. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pincer Nail
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Jul 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Medical or mental conditions that contraindicate surgical treatment of the condition.
About this study
A prospective design that studies the effects of a new technique for the treatment of pincer nails. The technique consists of a flattening of the bone of the distal phalanx with a frontal skin lifting that is performed in patients with a pincer nail deformity. Visual Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.
- Conditions
- Pincer Nail
- Being tested
- Surgery
- Keywords
- Pincer Nail, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Consists of a dorsal flattening of of the bone at the distal phalanx, with a frontal lifting of the distal skin of the toe Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain - 10 points Visual Analog Scale (VAS)
Measured: Change in Pain will be measured with a VAS: at baseline, after 1 month of treatment and after 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pincer 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clínica María del Mar Ruiz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA DEL MAR RUIZ HERRERA, Clínica María del Mar Ruiz
- Investigators
- Mª del Mar Ruíz-Herrera, DPM, Study director, Mª del Mar Ruiz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939521
- Sponsor's protocol ID
- Maria del Mar Ruiz-Herrera
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstructive Surgical Approach for Pincer Nail
- ClinicalTrials.gov ID
- NCT02939521
- Acronym / sponsor ID
- Maria del Mar Ruiz-Herrera
- Conditions
- Pincer Nail
- Keywords
- Pincer Nail, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Clínica María del Mar RuizUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Oct 2016 (estimated)
- 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.
A prospective design that studies the effects of a new technique for the treatment of pincer nails. The technique consists of a flattening of the bone of the distal phalanx with a frontal skin lifting that is performed in patients with a pincer nail deformity. Visual Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: SurgeryConsists of a dorsal flattening of of the bone at the distal phalanx, with a frontal lifting of the distal skin of the toe |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Medical or mental conditions that contraindicate surgical treatment of the condition.
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 |
|---|---|---|
| Surgery | Procedure or surgery | Surgery |
Primary outcome
Change in Pain - 10 points Visual Analog Scale (VAS)
Time frame: Change in Pain will be measured with a VAS: at baseline, after 1 month of treatment and after 1 year after treatment
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 20 Oct 2016.
- Individual participant dataSharing planned: No
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.
Mª del Mar Ruíz-Herrera, DPM study director
Mª del Mar Ruiz Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Surgery in people with Pincer Nail, run by Clínica María del Mar Ruiz.
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 0 inclusion and 1 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 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Pain - 10 points Visual Analog Scale (VAS) (time frame: Change in Pain will be measured with a VAS: at baseline, after 1 month of treatment and after 1 year after treatment). 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 20 Oct 2016.