Diabetes MellitusPhase 3SANIBANCT01586481
Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers
A Phase 3 study testing SANIDIAB and BAROUK in people with Diabetes Mellitus and Diabetic Neuropathic Foot Ulcer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Neuropathic Foot Ulcer
- What is being tested?
- SANIDIAB and BAROUK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Feb 2013
- Phase
- Phase 3
- 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
Who may be able to join
- More of 18 years old man or woman
- Type 1 or 2 Diabetes mellitus
- A new plantar ulcer of the fore foot or the toes
- GRADE 1A or 2 A of the University of Texas Classification
- Neuropathy assessed by absence of sensation in 10g monofilament test
Who cannot join
- Severe angiopathy (Grade 3 of the PEDIS classification)
- Osteomyelitis or cellulitis of the foot
- Transmetatarsal amputation
- Other study in course
- Immunosuppressive drugs, antibiotic therapy,
- Hepatic insufficiency
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- No possibility to follow the patients every 14 days
- No state health insurance
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of an Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers of the Fore Foot: a Prospective Randomised Pilot Study
It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe
Read the detailed description
Name of the study : SANIBA
Objective:
The gold standard to heal diabetic foot ulcers is complete off-loading. To wear continuously off loading shoe is very difficult The bad compliance of the patients can lead to infection of the ulcer and amputation of the foot.
The purpose of this study is to compare the efficacy of a new concept of off-loading shoe (a pair of SANIDIAB shoes) with a single BAROUK shoe to treat chronic plantar diabetic foot ulcer of the fore foot. The hypothesis is that the new concept is more efficient because of a good off-loading associated with a best compliance to wear the new concept of shoes.
The study will last 18 months with a duration of study of 6 months per patient It's a pilot prospective multicenter randomised study of 64 diabetic patients with a plantar neuropathic ulcer of the fore foot, treated after randomisation by an off loading shoe BAROUK or a pair of off loading shoes SANIDIAB.
Patients will be followed in a diabetic foot department every 14 days until healing and after healing until 6 months after inclusion in the study.
The main outcome measure is the healing duration of the diabetic foot ulcers in both group of treatment.
The secondary outcome measure is the rate of reulceration after healing , the rate of amputation and compliance of patients 64 patients will be included in 2 groups: 32 will wear SANIDIAB shoes and 32 BAROUK shoe.
- Conditions
- Diabetes Mellitus, Diabetic Neuropathic Foot Ulcer
- Being tested
- SANIDIAB, BAROUK
- Keywords
- Diabetic foot ulcer, Off loading, Compliance, Healing duration, Amputation rate
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANIDIABDevice
off-loading shoe
BAROUKDevice
old shoe
| Study group | Role | What they receive |
|---|---|---|
| barouk | Active comparator | Not described Receives: Device: BAROUK |
| sanidiab | Experimental | Not described Receives: Device: SANIDIAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing duration of the diabetic foot ulcer
Measured: 6 months
Secondary outcomes (3)
Rate of reulceration
Measured: 6 months
Rate of amputation
Measured: 6 months
Compliance of patients to footwear
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- MAYZAUD
- Responsible party
- Sponsor
- Investigators
- Georges HA VAN, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586481
- Sponsor's protocol ID
- P090501
- Acronym
- SANIBA
- Status last verified
- May 2013
- First submitted
- 25 Apr 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of an Off- Loading Shoe to Improve Healing and Prevention of Recurrence of Neuropathic Diabetic Plantar Foot Ulcers of the Fore Foot: a Prospective Randomised Pilot Study
- ClinicalTrials.gov ID
- NCT01586481
- Acronym / sponsor ID
- SANIBA / P090501
- Conditions
- Diabetes Mellitus, Diabetic Neuropathic Foot Ulcer
- Keywords
- Diabetic foot ulcer, Off loading, Compliance, Healing duration, Amputation rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- MAYZAUD
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Apr 2012 (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.
It's a pilot prospective opened multicentric randomised study. We measure the efficiency and the safety of a new concept of off-loading shoe (SANIDIAB) compared with an old one (BAROUK) to treat chronic diabetic foot ulcer which involved a high risks of amputation 64 diabetic patients with a plantar neuropathic ulcer of the fore foot without infection, osteomyelitis or angiopathy, will be included. 32 patients will be treated with SANIDIAB shoe and 32 with BAROUK shoe
Detailed description
Name of the study : SANIBA
Objective:
The gold standard to heal diabetic foot ulcers is complete off-loading. To wear continuously off loading shoe is very difficult The bad compliance of the patients can lead to infection of the ulcer and amputation of the foot.
The purpose of this study is to compare the efficacy of a new concept of off-loading shoe (a pair of SANIDIAB shoes) with a single BAROUK shoe to treat chronic plantar diabetic foot ulcer of the fore foot. The hypothesis is that the new concept is more efficient because of a good off-loading associated with a best compliance to wear the new concept of shoes.
The study will last 18 months with a duration of study of 6 months per patient It's a pilot prospective multicenter randomised study of 64 diabetic patients with a plantar neuropathic ulcer of the fore foot, treated after randomisation by an off loading shoe BAROUK or a pair of off loading shoes SANIDIAB.
Patients will be followed in a diabetic foot department every 14 days until healing and after healing until 6 months after inclusion in the study.
The main outcome measure is the healing duration of the diabetic foot ulcers in both group of treatment.
The secondary outcome measure is the rate of reulceration after healing , the rate of amputation and compliance of patients 64 patients will be included in 2 groups: 32 will wear SANIDIAB shoes and 32 BAROUK shoe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| barouk | Active comparator | Device: BAROUK |
| sanidiab | Experimental | Device: SANIDIAB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- More of 18 years old man or woman
- Type 1 or 2 Diabetes mellitus
- A new plantar ulcer of the fore foot or the toes
- GRADE 1A or 2 A of the University of Texas Classification
- Neuropathy assessed by absence of sensation in 10g monofilament test
Key exclusion criteria (9 listed)
- Severe angiopathy (Grade 3 of the PEDIS classification)
- Osteomyelitis or cellulitis of the foot
- Transmetatarsal amputation
- Other study in course
- Immunosuppressive drugs, antibiotic therapy,
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 |
|---|---|---|
| SANIDIABoff-loading shoe | Device | sanidiab |
| BAROUKold shoe | Device | barouk |
Primary outcome
Healing duration of the diabetic foot ulcer
Time frame: 6 months
3 secondary outcomes
Rate of reulceration
Time frame: 6 months
Rate of amputation
Time frame: 6 months
Compliance of patients to footwear
Time frame: 6 months
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 14 Nov 2013.
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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.
Georges HA VAN, MD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SANIDIAB and BAROUK in people with Diabetes Mellitus and Diabetic Neuropathic Foot Ulcer, run by Assistance Publique - Hôpitaux de Paris 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 9 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 14 Nov 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Healing duration of the diabetic foot ulcer (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2013.