Clinical trial NCT04892771: Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer
Official title: Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Foot
Keywords: Diabetic foot ulcer
Recurrence
Prevention
Remission
Follow-up
Multidisciplinary team
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of wound
timeFrame: At 2 years
Secondary outcomes:
measure: Hospitalisation
timeFrame: At 2 years
measure: Number of visits to the pedicure
timeFrame: At 2 years
measure: Adequate footwear
timeFrame: At 2 years
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.