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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588258
• Other study ID #: 21/633-EC_X
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: October 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

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.

Locations

Country	Name	City	State
Spain	José Luis Lázaro Martínez	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.	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
Primary	Assessment of the skin quality of participants' feet before and after the cream application intervention using a validated questionnaire.	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