Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer (Pied-REM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04892771
Recruitment Status : Recruiting
First Posted : May 19, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Sud Francilien

Brief Summary:
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.

Condition or disease
Diabetic Foot

Detailed Description:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 158 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer
Estimated Study Start Date : June 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Experimental group
Patients who have honored two consultations per year for two years.
Control group
Patients who have not honored two consultations per year for two years.



Primary Outcome Measures :
  1. Number of wound [ Time Frame: At 2 years ]
    Diabetic foot ulcer recurrence


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diabetic foot ulcer healed who were followed-up in CHSF. All these patients have a high podological risk.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04892771


Contacts
Layout table for location contacts
Contact: Marie BOULY, APN (Advanced Practice Nurse) (33) 1.61.69.34.04 marie.bouly@chsf.fr
Contact: Caroline TOURTE (33) 1 61 69 31 50 caroline.tourte@chsf.fr

Locations
Layout table for location information
France
Centre Hospitalier Sud Francilien Recruiting
Corbeil-Essonnes, France, 91100
Contact: Marie BOULY, APN    (33) 1.61.69.34.04    marie.bouly@chsf.fr   
Sponsors and Collaborators
Centre Hospitalier Sud Francilien
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier: NCT04892771    
Other Study ID Numbers: 2021/0027
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Sud Francilien:
Diabetic foot ulcer
Recurrence
Prevention
Remission
Follow-up
Multidisciplinary team
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases