NCT02939521

Brief 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. Visual Analog Scale (VAS) will be measure before surgery, one month and one year after surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

October 12, 2016

Last Update Submit

October 19, 2016

Conditions

Pincer Nail

Keywords

Pincer NailSurgery

Outcome Measures

Primary Outcomes (1)

  • Change in Pain - 10 points Visual Analog Scale (VAS)

    Change in Pain will be measured with a VAS: at baseline, after 1 month of treatment and after 1 year after treatment

Study Arms (1)

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

Procedure: Surgery

Interventions

SurgeryPROCEDURE
Surgery

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Medical or mental conditions that contraindicate surgical treatment of the condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Mª del Mar Ruíz-Herrera, DPM

    Mª del Mar Ruiz Clinic

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 20, 2016

Study Start

September 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 20, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share