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OpenTrials
Completed

NCT Number: NCT05214586

Conservative Treatment of Ingrown Toenail

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.

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Key information

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alfonso Martínez Nova

Plasencia, Cáceres, 10600, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow up of the clinical stage

Procedure

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

Primary outcomes

  1. Recurrence of the disease

    Time frame: 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 outcomes

  1. Reported pain

    Time frame: Every clinic visit of the patient until 3 months

    Visual analogue scale of pain (0-10)

  2. Infection

    Time frame: 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.

  3. Swelling

    Time frame: Every clinic visit of the patient until 3 months

    Presence of swelling symptoms as pain, redness and hardardening around the affected toenail.

  4. Patient satisfaction

    Time frame: Every clinic visit of the patient until 3 months

    Patient satisfaction survey (0-10)

Sponsors and collaborators

Lead sponsor

Universidad de Extremadura

Other

Collaborators

  • University of Valencia

Registry information

Official study title

Conservative Treatment of Ingrown Toenail in Stages I or IIa

Acronym: TOCON

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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