Conservative Treatment of Ingrown Toenail

NCT05214586 | Completed DMC

• 1 other identifier: TOCON
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Ingrown toenail; Conservative treatment; Recurrence; Podiatry; Nail remodelling

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (4)

• Reported pain

  Every clinic visit of the patient until 3 months

• Infection

  Every clinic visit of the patient until 3 months

• Swelling

  Every clinic visit of the patient until 3 months

• Patient satisfaction

  Every clinic visit of the patient until 3 months

Study Arms (2)

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.

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.

Procedure: Follow up of the clinical stage

Interventions

Follow up of the clinical stage PROCEDURE

Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured

Spiculotomy and Nail Re-education with Gauze Bandage; Spiculotomy and application of a Gel Nail

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ingrown toenail in stage I or IIa (Mozena Classification)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Extremadura: lead
• University of Valencia: collaborator

Study Sites (1)

Alfonso Martínez Nova

Plasencia, Cáceres, 10600, Spain

Location

MeSH Terms

Conditions

Nails, Ingrown; Nails, Malformed; Recurrence

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 28, 2022
• Study Start: February 1, 2022
• Primary Completion: April 30, 2022
• Study Completion: May 30, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

ES (1)