Conservative Treatment of Ingrown Toenail (TOCON)

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.

Study Overview

• Status: Completed
• Conditions: Ingrown Nail; Nails, Abnormal
• Intervention / Treatment: Procedure: Follow up of the clinical stage

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cáceres
    • Plasencia, Cáceres, Spain, 10600
      • Alfonso Martínez Nova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spiculotomy and application of a Gel Nail; 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; Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured
Active Comparator: Spiculotomy and Nail Re-education with Gauze Bandage; 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; Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reported pain	Visual analogue scale of pain (0-10)	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.	Every clinic visit of the patient until 3 months
Swelling	Presence of swelling symptoms as pain, redness and hardardening around the affected toenail.	Every clinic visit of the patient until 3 months
Patient satisfaction	Patient satisfaction survey (0-10)	Every clinic visit of the patient until 3 months

Collaborators and Investigators

• Sponsor: Universidad de Extremadura
• Collaborators: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Recurrence; Conservative treatment; Podiatry; Ingrown toenail; Nail remodelling
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Nail Diseases; Nails, Malformed; Nails, Ingrown
• Other Study ID Numbers: TOCON

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No