Diabetic FootPied-REMNCT04892771
Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer
An observational study of Diabetic Foot, run by Centre Hospitalier Sud Francilien at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2021to 21 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diabetic foot ulcer healed who were followed-up in CHSF. All these patients have a high podological risk.
Who may be able to join
- 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.
Who cannot join
- Person refusing the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot ulcer, Recurrence, Prevention, Remission, Follow-up, Multidisciplinary team
- Medical subject headings
- Diabetic Foot, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of wound
Diabetic foot ulcer recurrence
Measured: At 2 years
Secondary outcomes (3)
Hospitalisation
Days of hospitalisation for diabetic foot ulcer
Measured: At 2 years
Number of visits to the pedicure
Podology follow-up
Measured: At 2 years
Adequate footwear
Wearing of adequate shoes
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start20 May 2021
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892771
- Sponsor's protocol ID
- 2021/0027
- Acronym
- Pied-REM
- Status last verified
- Jan 2022
- First submitted
- 14 May 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26340966Bus 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.
PubMed 26334001Bus 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.
PubMed 24130357Armstrong 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.
PubMed 28614678
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-healing Follow-up Study in People With Remission of a Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT04892771
- Acronym / sponsor ID
- Pied-REM / 2021/0027
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot ulcer, Recurrence, Prevention, Remission, Follow-up, Multidisciplinary team
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diabetic foot ulcer healed who were followed-up in CHSF. All these patients have a high podological risk.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Person refusing the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of wound
Time frame: At 2 years
Diabetic foot ulcer recurrence
3 secondary outcomes
Hospitalisation
Time frame: At 2 years
Number of visits to the pedicure
Time frame: At 2 years
Adequate footwear
Time frame: At 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Background: PubMed 26340966van 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.
- Background: PubMed 26334001Bus 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.
- Background: PubMed 24130357Bus 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.
- Background: PubMed 28614678Armstrong 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.
- French diabetology societyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot, run by Centre Hospitalier Sud Francilien at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of wound (time frame: At 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04892771, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.