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Conservative Treatment of Ingrown Toenail (TOCON)

Primary Purpose

Ingrown Nail, Nails, Abnormal

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Follow up of the clinical stage
Sponsored by
Universidad de Extremadura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ingrown Nail focused on measuring Ingrown toenail, Conservative treatment, Recurrence, Podiatry, Nail remodelling

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alfonso Martínez Nova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spiculotomy and application of a Gel Nail

Spiculotomy and Nail Re-education with Gauze Bandage

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reported pain
Visual analogue scale of pain (0-10)
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.
Swelling
Presence of swelling symptoms as pain, redness and hardardening around the affected toenail.
Patient satisfaction
Patient satisfaction survey (0-10)

Full Information

First Posted
December 30, 2021
Last Updated
May 30, 2022
Sponsor
Universidad de Extremadura
Collaborators
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT05214586
Brief Title
Conservative Treatment of Ingrown Toenail
Acronym
TOCON
Official Title
Conservative Treatment of Ingrown Toenail in Stages I or IIa
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Extremadura
Collaborators
University of Valencia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ingrown Nail, Nails, Abnormal
Keywords
Ingrown toenail, Conservative treatment, Recurrence, Podiatry, Nail remodelling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spiculotomy and application of a Gel Nail
Arm Type
Experimental
Arm Description
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.
Arm Title
Spiculotomy and Nail Re-education with Gauze Bandage
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Follow up of the clinical stage
Intervention Description
Pain, Swelling, Infection, Patient satisfaction and recurrence of the disease will be measured
Primary Outcome Measure Information:
Title
Recurrence of the disease
Description
Recurrence is defined as a return of the previous symptoms, regrowth of the nail edge, or patient dissatisfaction with the clinical outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Reported pain
Description
Visual analogue scale of pain (0-10)
Time Frame
Every clinic visit of the patient until 3 months
Title
Infection
Description
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.
Time Frame
Every clinic visit of the patient until 3 months
Title
Swelling
Description
Presence of swelling symptoms as pain, redness and hardardening around the affected toenail.
Time Frame
Every clinic visit of the patient until 3 months
Title
Patient satisfaction
Description
Patient satisfaction survey (0-10)
Time Frame
Every clinic visit of the patient until 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alfonso Martínez Nova
City
Plasencia
State/Province
Cáceres
ZIP/Postal Code
10600
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Conservative Treatment of Ingrown Toenail

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