- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05588258
Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
Comparative, Randomised, Double-blind, Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
Study Overview
Status
Conditions
Detailed Description
The aim of this study was to evaluate the cost-effectiveness of two 10% urea creams in patients with Diabetic Foot Syndrome.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Madrid, Spain, 28040
- José Luis Lázaro Martínez
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients >18 years with Diabetic Foot Syndrome
- 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:
- Patients with hypersensitivity or allergy to any of the components of both creams.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Pharmacy cream 10% urea
Use of pharmacy cream in prevention
|
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 Names:
|
Active Comparator: Supermarket cream 10% urea
Use of supermarket cream in prevention
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.
Time Frame: 5 months
|
The cost analysis will be carried out considering the price per ml of 10% urea cream used by the participants during their participation in the study.
|
5 months
|
Assessment of the skin quality of participants' feet before and after the cream application intervention using a validated questionnaire.
Time Frame: 5 months
|
The assessment of skin quality was carried out using the "Questionnaire for assessment of injury risk and skin quality in patients with diabetic foot syndrome", validated intra-observer and inter-observer by this research group.
The minimum score assigned in this questionnaire is 0 points and the maximum score is 12, with higher scores correlating with higher risk of injury and poorer skin quality of the feet.
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5 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: José Luis Lázaro Martínez, Prof. Dr., Universidad Complutense de Madrid
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21/633-EC_X
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.
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