Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients

NCT03447925 | Completed Phase 2 DMC

• 1 other identifier: 65431417.4.0000.5102
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratosis Plantaris

Keywords

callosities; keratosis; diabetes mellitus; plants, medicinal; herbal medicine; keratolytic agents

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Study Arms (2)

Medicinal Plant X Salicylate

EXPERIMENTAL

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

Medicinal Plant X Vaseline

EXPERIMENTAL

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

Interventions

Medicinal Plant DRUG

Medicinal Plant Extract with vaseline cream

Also known as: Treatment Group (TG)

Medicinal Plant X Salicylate; Medicinal Plant X Vaseline

Salicylate DRUG

Salicylate 10% with vaseline cream

Also known as: Salicylate Group (SG)

Medicinal Plant X Salicylate

Vaseline DRUG

Vaseline cream

Also known as: Control Group (CG)

Medicinal Plant X Vaseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- diabetic patients type 1 and 2 with plantar keratosis

You may not qualify if:

• \- feet ulcerated lesions

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Beatriz B Martinez

Pouso Alegre, Minas Gerais, 37550312, Brazil

Location

Related Publications (2)

• 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.

  PMID: 26054651 RESULT

• 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.

  PMID: 22934545 RESULT

MeSH Terms

Conditions

Callosities; Keratosis; Diabetes Mellitus

Interventions

Salicylates; Petrolatum; Control Groups

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Universidade do Vale do Sapucai

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 27, 2018
• Study Start: June 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: January 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)