- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447925
Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients
Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients: Randomized, Double-Blind and Controlled Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minas Gerais
-
Pouso Alegre, Minas Gerais, Brazil, 37550312
- Beatriz B Martinez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diabetic patients type 1 and 2 with plantar keratosis
Exclusion Criteria:
- feet ulcerated lesions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Medicinal Plant Extract with vaseline cream
Other Names:
Salicylate 10% with vaseline cream
Other Names:
|
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.
|
Medicinal Plant Extract with vaseline cream
Other Names:
Vaseline cream
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Precancerous Conditions
- Keratosis, Actinic
- Keratosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Emollients
- Salicylic Acid
- Salicylates
- Petrolatum
Other Study ID Numbers
- 65431417.4.0000.5102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keratosis Plantaris
-
PeplinCompletedSeborrheic KeratosisAustralia
-
Stanford UniversityCompletedHyperhidrosis | Hyperhidrosis Palmaris et PlantarisUnited States
-
Aclaris Therapeutics, Inc.CompletedSeborrheic Keratosis (SK)United States
-
Sanotize Research and Development corp.Recruiting
-
DermBiont, Inc.Active, not recruitingA Trial to Evaluate the Safety and Efficacy of SM-020 Gel 1.0% in Subjects With Seborrheic KeratosisSeborrheic KeratosisUnited States
-
Aclaris Therapeutics, Inc.CompletedSeborrheic KeratosisUnited States
-
Dolorgiet GmbH & Co. KGd.s.h. statistical services GmbH; CenTrial GmbHCompletedActinic Keratosis Olsen Grade I/IIGermany
-
Dr. Reddy's Laboratories LimitedCompleted
-
Pulse Biosciences, Inc.CompletedSeborrheic Keratosis | Lesion SkinUnited States
-
DermBiont, Inc.Zepeda DermatologiaActive, not recruitingSeborrheic KeratosisEl Salvador
Clinical Trials on Medicinal Plant
-
Fenix Innovation GroupMonash Health; Neurotech InternationalNot yet recruitingAutism Spectrum DisorderAustralia
-
Federal University of ParaíbaConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedCerebral Palsy | Hemiplegia | Quadriplegia | Spastic DiplegiaFrance
-
Murdoch Childrens Research InstituteRecruiting
-
Michael FrassSigmund Freud PrivatUniversitatCompletedAdjustment Reaction With Physical SymptomsAustria
-
University of Colorado, DenverColorado Department of Public Health and EnvironmentUnknownEpilepsy, Unspecified, Refractory (Medically)United States
-
Longeveron Inc.The University of Texas Health Science Center, Houston; National Heart, Lung... and other collaboratorsRecruitingHypoplastic Left Heart SyndromeUnited States
-
Fudan UniversityState Administration of Traditional Chinese Medicine of the People's Republic...CompletedParkinson's DiseaseChina