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

Not Applicable

Completed

• Conditions: Diabetic Foot
• Interventions: 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.

• Registration Number: NCT05588258
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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

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 Timeline

• Study Start: 2021-11-02
• Primary Completion: 2022-04-30
• Study Completion: 2022-05-31
• Study First Submitted: 2022-09-30
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacy cream 10% urea	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.	Use of pharmacy cream in prevention
Supermarket cream 10% urea	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.	Use of supermarket cream in prevention

Primary Outcome Measures

Name	Time	Method
Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.	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.
Assessment of the skin quality of participants' feet before and after the cream application intervention using a validated questionnaire.	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.

Trial Locations

Locations (1)

José Luis Lázaro Martínez; 🇪🇸 Madrid, Spain