Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome

October 17, 2022 updated by: Jose Luis Lazaro Martinez, Universidad Complutense de Madrid

Comparative, Randomised, Double-blind, Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome

Randomised, double-blind, cost-effectiveness clinical trial of two 10% urea creams purchased in pharmacies and supermarkets in patients with diabetic foot syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • José Luis Lázaro Martínez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pharmacy cream 10% urea
Use of pharmacy cream in prevention
Other: 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 Names:
  • After one month of application of the 10% urea cream assigned after randomisation, the skin quality of the participants' feet was re-evaluated by means of a validated questionnaire.
Active Comparator: Supermarket cream 10% urea
Use of supermarket cream in prevention
Other: 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 Names:
  • After one month of application of the 10% urea cream assigned after randomisation, the skin quality of the participants' feet was re-evaluated by means of a validated questionnaire.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Complutense de Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: José Luis Lázaro Martínez, Prof. Dr., Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21/633-EC_X

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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