Keratosis PlantarisPhase 2NCT03447925
Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients
A Phase 2 study testing Medicinal Plant, Salicylate and Vaseline in people with Keratosis Plantaris, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratosis Plantaris
- What is being tested?
- Medicinal Plant, Salicylate and Vaseline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2017to 1 Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetic patients type 1 and 2 with plantar keratosis
Who cannot join
- feet ulcerated lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients: Randomized, Double-Blind and Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Keratosis Plantaris
- Being tested
- Medicinal Plant, Salicylate, Vaseline
- Keywords
- callosities; keratosis; diabetes mellitus; plants, medicinal; herbal medicine; keratolytic agents
- Medical subject headings
- Callosities, Keratosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicinal PlantDrug
Also called Treatment Group (TG)
Medicinal Plant Extract with vaseline cream
SalicylateDrug
Also called Salicylate Group (SG)
Salicylate 10% with vaseline cream
VaselineDrug
Also called Control Group (CG)
Vaseline cream
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Medicinal Plant; Drug: Vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jun 2017
- Primary completion1 Mar 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Keratosis PlantarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Bertolaccini Martínez, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447925
- Sponsor's protocol ID
- 65431417.4.0000.5102
- Status last verified
- Nov 2020
- First submitted
- 20 Feb 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26054651Caravaggi 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.
PubMed 22934545
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients: Randomized, Double-Blind and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03447925
- Acronym / sponsor ID
- 65431417.4.0000.5102
- Conditions
- Keratosis Plantaris
- Keywords
- callosities; keratosis; diabetes mellitus; plants, medicinal; herbal medicine; keratolytic agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicinal Plant X Salicylate | Experimental | Drug: Medicinal Plant, Drug: SalicylateTreatment 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 X Vaseline | Experimental | Drug: Medicinal Plant, Drug: VaselineTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic patients type 1 and 2 with plantar keratosis
Key exclusion criteria (1 listed)
- feet ulcerated lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicinal PlantAlso: Treatment Group (TG)Medicinal Plant Extract with vaseline cream | Drug | Medicinal Plant X Salicylate, Medicinal Plant X Vaseline |
| SalicylateAlso: Salicylate Group (SG)Salicylate 10% with vaseline cream | Drug | Medicinal Plant X Salicylate |
| VaselineAlso: Control Group (CG)Vaseline cream | Drug | Medicinal Plant X Vaseline |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Results publication: PubMed 26054651Arosi 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 publication: PubMed 22934545Caravaggi 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medicinal Plant, Salicylate and Vaseline in people with Keratosis Plantaris, run by Universidade do Vale do Sapucai at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of the sites with plantar keratosis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.