NCT04789083

Brief Summary

Tineapedis is an important health problem. Providing foot care in tinea pedis treatment contributes positively to the treatment. In addition, alternative treatments can also be used. In this study, the randomization study group will be divided into three. Medical treatment and foot care training will be applied to the first group, medical treatment and propolis to the second group, medical treatment and plassebo to the control group. Foot care training will be given by nurse coaching. Times of all three groups and their response to treatment will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 9, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

February 3, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

December 10, 2020

Last Update Submit

February 1, 2023

Conditions

Keywords

nursingnurse coachingpatient educationcomplementary therapyalthernative therapy

Outcome Measures

Primary Outcomes (1)

  • Evaluation

    Dermatological Quality of Life Scale

    3 month

Secondary Outcomes (1)

  • Doctor's an patient's global

    3 month

Study Arms (3)

Group 1 (Propolis)

EXPERIMENTAL

Medical therapy and propolis

Other: Propholis extrate

Group 2 (Nurse Coaching/ Nursing education)

EXPERIMENTAL

Medical treatment and nurse coaching

Other: Propholis extrate

Group 3 (Plassebo)

PLACEBO COMPARATOR

Medical treatment and plassebo will be applied.

Other: Propholis extrate

Interventions

Plassebo

Also known as: Nurse coaching/ Nursing education
Group 1 (Propolis)Group 2 (Nurse Coaching/ Nursing education)Group 3 (Plassebo)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not being pregnant
  • Not being breastfeeding
  • Not having confusion
  • Not being immunosuppressed
  • Not using systemic cortisone
  • Not having any dermatological problems (psoriasis, contact dermatitis, etc.) that will affect the treatment.
  • Agree to participate in research
  • Being accessible by phone
  • Having no problems communicating by phone
  • Not having problems with physical care

You may not qualify if:

  • Pregnant / nursing women
  • Using systemic antifungal therapy
  • Using systemic croticosteroids
  • In the process of treatment for oncological reasons
  • Are using immunosuppressants
  • Dermatological disease (contact dermatitis, psoriasis)
  • Under the age of 18 and over the age of 64
  • Have cognitive problems
  • There is no telephone / telephone number within reach
  • Individuals who have difficulties in speaking and understanding Turkish will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Univercity

Konya, 42370, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a double blind randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assit. Prof.

Study Record Dates

First Submitted

December 10, 2020

First Posted

March 9, 2021

Study Start

February 3, 2022

Primary Completion

August 19, 2022

Study Completion

August 30, 2022

Last Updated

February 2, 2023

Record last verified: 2023-02

Locations