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

NCT04892771 | Completed

• 1 other identifier: 2021/0027
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetic foot ulcer; Recurrence; Prevention; Remission; Follow-up; Multidisciplinary team

Outcome Measures

Primary Outcomes (1)

• Number of wound

  Diabetic foot ulcer recurrence

  At 2 years

Secondary Outcomes (3)

• Hospitalisation

  At 2 years

• Number of visits to the pedicure

  At 2 years

• Adequate footwear

  At 2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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,
• years of âge or older,
• Person not deprived of liberty,
• person who was informed of and did not object to the study.

You may not qualify if:

• \- Person refusing the study.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Related Publications (4)

• 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.

  PMID: 26340966 BACKGROUND

• 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.

  PMID: 26334001 BACKGROUND

• 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.

  PMID: 24130357 BACKGROUND

• 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.

  PMID: 28614678 BACKGROUND

Related Links

• French diabetology society

MeSH Terms

Conditions

Diabetic Foot; Recurrence

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: May 20, 2021
• Primary Completion: December 21, 2021
• Study Completion: December 21, 2021
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)