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

NCT ID: NCT04892771

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2021-12-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Foot

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Experimental group

Patients who have honored two consultations per year for two years.

No interventions assigned to this group

Control group

Patients who have not honored two consultations per year for two years.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Sud Francilien

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

Site Status

Countries

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France

References

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van Netten JJ, Price PE, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Bus SA; International Working Group on the Diabetic Foot. Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:84-98. doi: 10.1002/dmrr.2701.

Reference Type BACKGROUND
PMID: 26340966 (View on PubMed)

Bus SA, van Netten JJ, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Price PE; International Working Group on the Diabetic Foot. IWGDF guidance on the prevention of foot ulcers in at-risk patients with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:16-24. doi: 10.1002/dmrr.2696. No abstract available.

Reference Type BACKGROUND
PMID: 26334001 (View on PubMed)

Bus SA, Waaijman R, Arts M, de Haart M, Busch-Westbroek T, van Baal J, Nollet F. Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial. Diabetes Care. 2013 Dec;36(12):4109-16. doi: 10.2337/dc13-0996. Epub 2013 Oct 15.

Reference Type BACKGROUND
PMID: 24130357 (View on PubMed)

Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

Reference Type BACKGROUND
PMID: 28614678 (View on PubMed)

Related Links

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http://www.sfdiabete.org

French diabetology society

Other Identifiers

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2021/0027

Identifier Type: -

Identifier Source: org_study_id

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