Conservative Treatment of Ingrown Toenail

Not Applicable

Completed

• Conditions: Nails, Abnormal; Ingrown Nail
• Interventions: Procedure: Follow up of the clinical stage

• Registration Number: NCT05214586
• Lead Sponsor: Universidad de Extremadura

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Study Start: 2022-02-01
• Primary Completion: 2022-04-30
• Status Verified: 2022-05
• Study Completion: 2022-05-30
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spiculotomy and Nail Re-education with Gauze Bandage	Follow up of the clinical stage	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.
Spiculotomy and application of a Gel Nail	Follow up of the clinical stage	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.

Primary Outcome Measures

Name	Time	Method
Recurrence of the disease	3 months	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

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

Trial Locations

Locations (1)

Alfonso Martínez Nova; 🇪🇸 Plasencia, Cáceres, Spain