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

Diabetic Foot Clinical Trial

— Pied-REM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892771
• Other study ID #: 2021/0027
• Status: Completed
• Start date: May 20, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: January 2022
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of wound	Diabetic foot ulcer recurrence	At 2 years
Secondary	Hospitalisation	Days of hospitalisation for diabetic foot ulcer	At 2 years
Secondary	Number of visits to the pedicure	Podology follow-up	At 2 years
Secondary	Adequate footwear	Wearing of adequate shoes	At 2 years

External Links

•   French diabetology society