Clinical trial NCT03447925: Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients
Official title: Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients: Randomized, Double-Blind and Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratosis Plantaris
Keywords: callosities; keratosis; diabetes mellitus; plants, medicinal; herbal medicine; keratolytic agents
Lead sponsor: Universidade do Vale do Sapucai
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

- diabetic patients type 1 and 2 with plantar keratosis

Exclusion Criteria:

- feet ulcerated lesions

Primary outcomes:
measure: Measures of the sites with plantar keratosis
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pouso Alegre
country: Brazil
facility: Beatriz B Martinez
state: Minas Gerais
Study officials:
References:
citation: Arosi I, Hiner G, Rajbhandari S. Pathogenesis and Treatment of Callus in the Diabetic Foot. Curr Diabetes Rev. 2016;12(3):179-83. doi: 10.2174/1573399811666150609160219.
citation: Caravaggi C, Sganzaroli A, Galenda P, Bassetti M, Ferraresi R, Gabrielli L. The management of the infected diabetic foot. Curr Diabetes Rev. 2013 Jan 1;9(1):7-24.