Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
NCT ID: NCT05588258
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2021-11-02
2022-05-31
Brief Summary
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Detailed Description
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The methodology was a prospective, longitudinal, single-centre, randomised, double-blind, longitudinal clinical trial that evaluated the skin quality of 20 participating feet belonging to 10 patients with Diabetic Foot Syndrome after the application of two 10% urea creams purchased in pharmacies and supermarkets.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Pharmacy cream 10% urea
Use of pharmacy cream in prevention
Participants were given the 10% urea cream purchased in pharmacy or supermarket as appropriate after randomisation and their foot skin quality was assessed by validated questionnaire.
Participants agreed to the interventions after allocation to each arm according to randomisation and after signing an informed consent form. The creams tested in this study provided to participants are authorised for sale within the European Union but are not considered drugs or medical devices. The main purpose of the interventions was based on the care and assessment of the quality of the skin of the participants' feet.
Supermarket cream 10% urea
Use of supermarket cream in prevention
Participants were given the 10% urea cream purchased in pharmacy or supermarket as appropriate after randomisation and their foot skin quality was assessed by validated questionnaire.
Participants agreed to the interventions after allocation to each arm according to randomisation and after signing an informed consent form. The creams tested in this study provided to participants are authorised for sale within the European Union but are not considered drugs or medical devices. The main purpose of the interventions was based on the care and assessment of the quality of the skin of the participants' feet.
Interventions
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Participants were given the 10% urea cream purchased in pharmacy or supermarket as appropriate after randomisation and their foot skin quality was assessed by validated questionnaire.
Participants agreed to the interventions after allocation to each arm according to randomisation and after signing an informed consent form. The creams tested in this study provided to participants are authorised for sale within the European Union but are not considered drugs or medical devices. The main purpose of the interventions was based on the care and assessment of the quality of the skin of the participants' feet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Deep or superficial sensory neurological involvement diagnosed by Semmes-Weinstein Monofilament and Rydel-Seiffer tuning fork
* ABI (Ankle Brachial Index) in normal range
* Metabolic Syndrome
* No cognitive impairment
* Patients who agreed to be included in the study by signing a written consent
Exclusion Criteria
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Jose Luis Lazaro Martinez
Prof. Dr.
Principal Investigators
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José Luis Lázaro Martínez, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
Locations
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José Luis Lázaro Martínez
Madrid, , Spain
Countries
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Other Identifiers
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21/633-EC_X
Identifier Type: -
Identifier Source: org_study_id
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