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Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

Primary Purpose

Keratosis Plantaris

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Medicinal Plant
Salicylate
Vaseline
Sponsored by
Universidade do Vale do Sapucai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratosis Plantaris focused on measuring callosities; keratosis; diabetes mellitus; plants, medicinal; herbal medicine; keratolytic agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- diabetic patients type 1 and 2 with plantar keratosis

Exclusion Criteria:

- feet ulcerated lesions

Sites / Locations

  • Beatriz B Martinez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Medicinal Plant X Salicylate

Medicinal Plant X Vaseline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 20, 2018
Last Updated
November 4, 2020
Sponsor
Universidade do Vale do Sapucai
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1. Study Identification

Unique Protocol Identification Number
NCT03447925
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Vale do Sapucai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratosis Plantaris
Keywords
callosities; keratosis; diabetes mellitus; plants, medicinal; herbal medicine; keratolytic agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medicinal Plant X Salicylate
Arm Type
Experimental
Arm Description
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.
Arm Title
Medicinal Plant X Vaseline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Medicinal Plant
Other Intervention Name(s)
Treatment Group (TG)
Intervention Description
Medicinal Plant Extract with vaseline cream
Intervention Type
Drug
Intervention Name(s)
Salicylate
Other Intervention Name(s)
Salicylate Group (SG)
Intervention Description
Salicylate 10% with vaseline cream
Intervention Type
Drug
Intervention Name(s)
Vaseline
Other Intervention Name(s)
Control Group (CG)
Intervention Description
Vaseline cream
Primary Outcome Measure Information:
Title
Measures of the sites with plantar keratosis
Description
Measures of the sites with plantar keratosis will be made in the first, and 30th days of treatment
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - diabetic patients type 1 and 2 with plantar keratosis Exclusion Criteria: - feet ulcerated lesions
Facility Information:
Facility Name
Beatriz B Martinez
City
Pouso Alegre
State/Province
Minas Gerais
ZIP/Postal Code
37550312
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26054651
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.
Results Reference
result
PubMed Identifier
22934545
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.
Results Reference
result

Learn more about this trial

Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

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