search
Back to results

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

Primary Purpose

Diabetic Foot

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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.
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Foot

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • José Luis Lázaro Martínez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pharmacy cream 10% urea

Supermarket cream 10% urea

Arm Description

Use of pharmacy cream in prevention

Use of supermarket cream in prevention

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2022
Last Updated
October 17, 2022
Sponsor
Universidad Complutense de Madrid
search

1. Study Identification

Unique Protocol Identification Number
NCT05588258
Brief Title
Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
Official Title
Comparative, Randomised, Double-blind, Cost-effectiveness Evaluation of Two 10% Urea Creams in Patients With Diabetic Foot Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacy cream 10% urea
Arm Type
Active Comparator
Arm Description
Use of pharmacy cream in prevention
Arm Title
Supermarket cream 10% urea
Arm Type
Active Comparator
Arm Description
Use of supermarket cream in prevention
Intervention Type
Other
Intervention Name(s)
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.
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cost analysis of two 10% urea creams purchased in pharmacies and supermarkets.
Description
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.
Time Frame
5 months
Title
Assessment of the skin quality of participants' feet before and after the cream application intervention using a validated questionnaire.
Description
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.
Time Frame
5 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Luis Lázaro Martínez, Prof. Dr.
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
José Luis Lázaro Martínez
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs