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Completed

NCT Number: NCT04892771

Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer

To evaluate the benefit of multidisciplinary specific follow-up of patients with a healed diabetic foot ulcer at the rate of two annual consultation on wound recurrence.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Disease Attributes Endocrine System Diseases Foot Ulcer Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

About this study

Diabetic foot ulcer is a major world health problem with a very high recurrence rate, 50% at two years.

The main causes of diabetic foot ulcer recurrence are inadequate footwear, lack of podology care and lack of self-care. International recommendations call for regular podological monitoring to prevent recurrence of diabetic foot ulcer.

The "remission foot" consultation assesses recommended items and is offered to any healed patient at the rate of two annual visit.

A retrospective study on multidisciplinary specific follow-up may show a real efficacity on recurrence rate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with type 1 ou type 2 diabetes followed-up in Centre Hospitalier Sud Francilien,
  • Discharge from hospital for diabetic foot ulcer between 2017 and 2019 and post-healing follow-up for two years,
  • 18 years of âge or older,
  • Person not deprived of liberty,
  • person who was informed of and did not object to the study.

Exclusion criteria

  • Person refusing the study.

Treatment and study plan

Primary outcomes

  1. Number of wound

    Time frame: At 2 years

    Diabetic foot ulcer recurrence

Secondary outcomes

  1. Hospitalisation

    Time frame: At 2 years

    Days of hospitalisation for diabetic foot ulcer

  2. Number of visits to the pedicure

    Time frame: At 2 years

    Podology follow-up

  3. Adequate footwear

    Time frame: At 2 years

    Wearing of adequate shoes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: Pied-REM

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 19, 2021
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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