Diabetic NeuropathyPhase 4ERODNCT02891928
Evaluation of Rocker sOles in Diabetis
A Phase 4 study testing Rocker sole shoes and Normal shoes in people with Diabetic Neuropathy, run by University Hospital, Brest at 1 site in France.
Trial summary
The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Rocker sole shoes and Normal shoes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Jun 2016
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with Type 2 Diabetes
- Patients suffering from diabetic neuropathy diagnosed by the test in the monostrand
- Can walk without technical assistance
- Age from 18 to 75
- Having made his non-opposition
Who cannot join
- Presence of ulceration of the foot (or a history of this type)
- History of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy
The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.
Read the detailed description
Diabetes is a public health problem. The functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. Preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. Some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?
- Conditions
- Diabetic Neuropathy
- Being tested
- Rocker sole shoes, Normal shoes
- Keywords
- Type 2 diabetes, Diabetic neuropathy, Disorders of equilibrium, "Rocker sole" shoes, Walking
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocker sole shoesDevice
Measure of walk testing Measure of standing position
Normal shoesDevice
Measure of walk testing Measure of standing position
| Study group | Role | What they receive |
|---|---|---|
| with rocker sole | Experimental | patient were wearing the rocker soles shoes during investigation Receives: Device: Rocker sole shoes |
| without rocker sole | Placebo comparator | patient were wearing normal shoes during investigation Receives: Device: Normal shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anteroposterior displacement amount of the center of pressure with regard to the center of mass.
Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startDec 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Remy-Neris, Professor, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891928
- Sponsor's protocol ID
- ROCKER SOLE (RB 14.143)
- Acronym
- EROD
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2016
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data are not planned to be shared
Publications
Lumeau M, Lempereur M, Remy-Neris O. Assessment of the rocker sole shoes on postural stability in diabetic patients with distal sensory neuropathy. Comput Methods Biomech Biomed Engin. 2015;18 Suppl 1:1986-7. doi: 10.1080/10255842.2015.1070588. Epub 2015 Aug 13. No abstract available.
PubMed 26269202
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Standard Wearing Shoes With Rocker Sole Shoes in Diabetic Patients With Neuropathy
- ClinicalTrials.gov ID
- NCT02891928
- Acronym / sponsor ID
- EROD / ROCKER SOLE (RB 14.143)
- Conditions
- Diabetic Neuropathy
- Keywords
- Type 2 diabetes, Diabetic neuropathy, Disorders of equilibrium, "Rocker sole" shoes, Walking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
The purpose of this study is to determine if the wearing of shoes "rocker sole" type prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of equilibrium.
Detailed description
Diabetes is a public health problem. The functional prognosis is partly conditioned by the occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy. Preventive measures are necessary to avoid such complications: education, pedicure, suitable footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key objective is to avoid excessive pressure found at the level of the front-foot, favoring the appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole system associated with an elevation of the front-foot. Some, however, have shown that this type of shoe may be responsible for disorders of equilibrium to the healthy subject, what about at the diabetic patients, already at higher risk of postural disorders and falls?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with rocker sole | Experimental | Device: Rocker sole shoespatient were wearing the rocker soles shoes during investigation |
| without rocker sole | Placebo comparator | Device: Normal shoespatient were wearing normal shoes during investigation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with Type 2 Diabetes
- Patients suffering from diabetic neuropathy diagnosed by the test in the monostrand
- Can walk without technical assistance
- Age from 18 to 75
- Having made his non-opposition
Key exclusion criteria (2 listed)
- Presence of ulceration of the foot (or a history of this type)
- History of pathologies that could disturb the balance and walking independently of diabetes: vestibular diseases, ophthalmic diseases with decreased of visual acuity, neurological, musculoskeletal and rheumatic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocker sole shoesMeasure of walk testing Measure of standing position | Device | with rocker sole |
| Normal shoesMeasure of walk testing Measure of standing position | Device | without rocker sole |
Primary outcome
Anteroposterior displacement amount of the center of pressure with regard to the center of mass.
Time frame: Inclusion
Displacement of the center of pressure is measured during a 55 sec session of standing position with dedicated shoes with of force plateform
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 3 Dec 2025.
- Results publication: PubMed 26269202Lumeau M, Lempereur M, Remy-Neris O. Assessment of the rocker sole shoes on postural stability in diabetic patients with distal sensory neuropathy. Comput Methods Biomech Biomed Engin. 2015;18 Suppl 1:1986-7. doi: 10.1080/10255842.2015.1070588. Epub 2015 Aug 13. No abstract available.
- Individual participant dataSharing planned: No. Data are not planned to be shared
Related trials for Diabetic Neuropathy
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Olivier Remy-Neris, Professor principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocker sole shoes and Normal shoes in people with Diabetic Neuropathy, run by University Hospital, Brest 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 2 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 3 Dec 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Anteroposterior displacement amount of the center of pressure with regard to the center of mass. (time frame: Inclusion). 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 NCT02891928, which also lists 1 linked publication.
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 3 Dec 2025.