NCT05165758

Brief Summary

The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

December 8, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

December 8, 2021

Last Update Submit

September 12, 2022

Conditions

DiabetesDiabetes MellitusFoot Ulcer, DiabeticDiabetes Complications

Keywords

DiabeteDiabete complicationsDiabetic foot ulcersocio-economic disparities

Outcome Measures

Primary Outcomes (1)

  • Compare the levels of quality of life in diabetic subjects with and without foot ulcer

    The primary endpoint will be the score on the mental health dimension of the SF-36 score

    6 months

Secondary Outcomes (4)

  • Compare the levels of precarity in diabetic subjects with and without foot ulcer

    6 months

  • Compare the levels of quality of life according to the levels of HbA1c, in diabetic subjects with and without foot ulcer

    6 months

  • Compare the quality of life levels according to the duration of diabetes, in diabetic subjects with and without foot ulcer

    6 months

  • Compare the quality of life levels according to the type of antidiabetic treatment, in diabetic subjects with and without foot ulcer

    6 months

Study Arms (2)

Diabetic subjects without foot ulcer

27 diabetic subjects without foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé)

Other: Self-assessment questionnaires

Diabetic subjects with foot ulcer

54 diabetic subjects presenting foot ulcer will answer to the SF-36 score (mental health items) and to a french precarit index (EPICES:Evaluation de la précarité et des inégalités de santé dans les Centres d'examens de santé)

Other: Self-assessment questionnaires

Interventions

Self-assessment questionnairesOTHER

Subjects will pass the SF-36 score (mental health items) and the EPICES index

Diabetic subjects with foot ulcerDiabetic subjects without foot ulcer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic subjects

You may qualify if:

  • People of 18 years old and over,
  • Diabetics living in Martinique,
  • Patient having been informed of the research,
  • Patient agreeing to participate in the study.

You may not qualify if:

  • Minor patient,
  • Patients with confusional syndrome,
  • Patient presenting a cognitive state making it difficult to complete the questionnaire,
  • Patient under legal protection, under guardianship or under curatorship,
  • Patient who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Center of Martinique

Fort-de-France, Martinique, 97261, France

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic FootDiabetes Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetic Neuropathies

Study Officials

  • Miguel BOURGADE, MD

    University Hospital Center of Martinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 21, 2021

Study Start

January 21, 2022

Primary Completion

June 17, 2022

Study Completion

June 17, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)