NCT05588258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

September 30, 2022

Last Update Submit

October 17, 2022

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Pharmacy cream 10% urea

ACTIVE COMPARATOR

Use of pharmacy cream in prevention

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

Use of supermarket cream in prevention

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.

Interventions

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

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.

Also known as: 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.
Pharmacy cream 10% ureaSupermarket cream 10% urea

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with hypersensitivity or allergy to any of the components of both creams.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Luis Lázaro Martínez

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Dosage FormsSupermarkets

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesFood SupplyFood IndustryIndustryTechnology, Industry, and Agriculture

Study Officials

  • José Luis Lázaro Martínez, Prof. Dr.

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 20, 2022

Study Start

November 2, 2021

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

October 20, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)