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Completed

NCT Number: NCT03447925

Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

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.

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Key information

Conditions

Keratosis Plantaris Callosities Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Keratosis Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beatriz B Martinez

Pouso Alegre, Minas Gerais, 37550312, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • diabetic patients type 1 and 2 with plantar keratosis

Exclusion criteria

  • feet ulcerated lesions

Treatment and study plan

Medicinal Plant

Drug

Medicinal Plant Extract with vaseline cream

Other names: Treatment Group (TG)

Salicylate

Drug

Salicylate 10% with vaseline cream

Other names: Salicylate Group (SG)

Vaseline

Drug

Vaseline cream

Other names: Control Group (CG)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 27, 2018
Registry last updated
Nov 5, 2020

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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