A Phase 2 interventional study of Medicinal Plant and Salicylate in Keratosis Plantaris, sponsored by Universidade do Vale do Sapucai. Completed at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-05.
Sponsored by Universidade do Vale do Sapucai · Phase 2, Interventional, and Treatment
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.
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.
21 studies on the registry are indexed under Callosities; 1 is open to participants now.
This study's enrollment of 90 is above the median of 60 across 19 interventional studies indexed under Callosities.
Browse Callosities studies →Universidade do Vale do Sapucai is the lead sponsor of 28 studies on the registry; none are open to participants now.
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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 · Drug: Salicylate
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 · Drug: Vaseline
Medicinal Plant Extract with vaseline cream
Also known as: Treatment Group (TG)
Salicylate 10% with vaseline cream
Also known as: Salicylate Group (SG)
Vaseline cream
Also known as: Control Group (CG)
Measures of the sites with plantar keratosis
Measures of the sites with plantar keratosis will be made in the first, and 30th days of treatment
Time frame: 30 days
Plan to share: No
Ran from Jun 2017 to primary completion in Mar 2019, 21 months.
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Universidade do Vale do Sapucai