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

Universidad Complutense de Madrid

Status: Completed

Conditions: Diabetic Foot

Treatments: 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.

Study type: Interventional

Funder types: Other

Identifiers

NCT05588258

21/633-EC_X

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Pharmacy cream 10% urea

Active Comparator group

Description:

Use of pharmacy cream in prevention

Treatment:

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.

Supermarket cream 10% urea

Active Comparator group

Description:

Use of supermarket cream in prevention

Treatment:

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.