Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

November 4, 2020 updated by: Beatriz Bertolaccini Martínez, Universidade do Vale do Sapucai

Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients: Randomized, Double-Blind and Controlled Clinical Trial

This study evaluates the addition of medicinal plant in the treatment of diabetic foot keratosis. Half of participants will receive medicinal plant and other half will receive a placebo.

Study Overview

Status

Completed

Conditions

Detailed Description

Keratosis in feet or plantar callosity is an injury caused by friction or pressure in certain location of the skin. This is a common problem faced by diabetic patients, which usually cause subcutaneous tissue maceration, which favors bacterial invasion. It is responsible for the development of abscesses and ulcers. Ulcer is the main cause of non-traumatic amputation of the feet in diabetic patients. Treatment with medicinal plants is an ancient practice. Brazil has one of the richest floras in the world. Brazilian Ministry of Health recommends the rational use of medicinal plants and encourage the use of this practice by health professionals.

The medicinal plant used in this study is a keratolytic agent, healing, emollient, bactericide and fungicide. The purpose of this study is evaluate the effectiveness of this medicinal plant in the treatment of keratosis in diabetic patients. This study will be controlled, randomized, comparative with standard drug and double-blind. Will be included in the study 90 adult diabetic patients type 1 or 2, with keratosis, both sexes, but do not show feet ulcerated lesions. Patients will be randomised controlled trials in three groups, with 30 people in each, which will receive topical treatment with medicinal plant (treatment group, TG), salicylate 10% (salicylate group, SG) and vaseline cream (control group, CG). The treatment will be once a day, for 30 consecutive days. Numerical scores will be made of the sites with keratosis and individual areas and global measures in the first, 30th days of treatment. The results obtained will be submitted to statistical comparison. This research will follow the standards set by resolution 466/12 of the National Health Council, the Vale do Sapucaí University, for research with human beings and will be conducted in accordance with the ethical recommendations of the Declaration of Helsinki.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37550312
        • Beatriz B Martinez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- diabetic patients type 1 and 2 with plantar keratosis

Exclusion Criteria:

- feet ulcerated lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Medicinal Plant X Salicylate
Treatment Group (TG) will receive topical treatment with medicinal plant and Salicylate Group (SG) will receive topical treatment with salicylate 10%, both once a day, for 30 consecutive days.
Medicinal Plant Extract with vaseline cream
Other Names:
  • Treatment Group (TG)
Salicylate 10% with vaseline cream
Other Names:
  • Salicylate Group (SG)
EXPERIMENTAL: Medicinal Plant X Vaseline
Treatment Group (TG) will receive topical treatment with medicinal plant and Control Group (CG) will receive topical treatment with vaseline cream, both once a day, for 30 consecutive days.
Medicinal Plant Extract with vaseline cream
Other Names:
  • Treatment Group (TG)
Vaseline cream
Other Names:
  • Control Group (CG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measures of the sites with plantar keratosis
Time Frame: 30 days
Measures of the sites with plantar keratosis will be made in the first, and 30th days of treatment
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

January 1, 2020

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (ACTUAL)

February 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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