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Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

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Universidade do Vale do Sapucai

关键词

抽象

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.

描述

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.

日期

最后验证: 02/28/2019
首次提交: 02/19/2018
提交的预估入学人数: 02/19/2018
首次发布: 02/26/2018
上次提交的更新: 03/04/2019
最近更新发布: 03/05/2019
实际学习开始日期: 05/31/2017
预计主要完成日期: 09/30/2019
预计完成日期: 12/31/2019

状况或疾病

Keratosis Plantaris

干预/治疗

Drug: Medicinal Plant

Drug: Medicinal Plant X Salicylate

Drug: Medicinal Plant X Vaseline

相 2

手臂组

干预/治疗
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.
Drug: Medicinal Plant X Salicylate
Salicylate 10% with vaseline cream
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.
Drug: Medicinal Plant X Vaseline
Vaseline cream

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- diabetic patients type 1 and 2 with plantar keratosis

Exclusion Criteria:

- feet ulcerated lesions

结果

主要结果指标

1. Measures of the sites with plantar keratosis [30 days]

Measures of the sites with plantar keratosis will be made in the first, and 30th days of treatment

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