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Conservative Treatment of Ingrown Toenail (TOCON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05214586
Recruitment Status : Not yet recruiting
First Posted : January 28, 2022
Last Update Posted : January 28, 2022
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Alfonso Martínez Nova, 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.

Condition or disease Intervention/treatment Phase
Ingrown Nail Nails, Abnormal Procedure: Follow up of the clinical stage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Treatment of Ingrown Toenail in Stages I or IIa
Estimated Study Start Date : February 7, 2022
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : March 30, 2022

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214586


Contacts
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Contact: Alfonso Martínez Nova, PhD +34927257000 ext 53216 podoalf@unex.es
Contact: Javier De Francisco Morcillo, PhD +34927257000 morcillo@unex.es

Locations
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Spain
Alfonso Martínez Nova
Plasencia, Cáceres, Spain, 10600
Sponsors and Collaborators
Universidad de Extremadura
University of Valencia
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Responsible Party: Alfonso Martínez Nova, Professor, Universidad de Extremadura
ClinicalTrials.gov Identifier: NCT05214586    
Other Study ID Numbers: TOCON
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alfonso Martínez Nova, Universidad de Extremadura:
Ingrown toenail
Conservative treatment
Recurrence
Podiatry
Nail remodelling
Additional relevant MeSH terms:
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Nails, Ingrown
Nails, Malformed
Nail Diseases
Skin Diseases
Pathological Conditions, Anatomical