Comparative, Randomised, Double-blind, Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jose Luis Lazaro Martinez
Prof. Dr.
Universidad Complutense de Madrid