Open Cracked Heel in Diabetic Patients With PolyneuropathyNCT02045199
Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
A study testing Tested product : V0111 cream in people with Open Cracked Heel in Diabetic Patients With Polyneuropathy, run by Pierre Fabre Medicament at 20 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Open Cracked Heel in Diabetic Patients With Polyneuropathy
- What is being tested?
- Tested product : V0111 cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 193 participants
- Where
- 20 sitesin 2 countries
- Study dates
- Feb 2014to Mar 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus with neuropathy,
- Cracked open heel with at least one fissure Grade 2,
Who cannot join
- Open wound, skin infection, haemorrhagic crack on feet,
- Major static disorder ,
- Ulceration and history of ulceration,
- Active haemorrhagic crack,
- Hyperkeratotic disease
- Diabetic arteriopathy,
Trial locations and contacts
20 sites in 2 countries.
20 sites in 2 countries
France17 sites
Study site
Angers
Study site
Bron
Study site
La Rochelle
Study site
Laval
Study site
Mantes-la-Jolie
Study site
Muret
Study site
Nanterre
Study site
Nice
Study site
Nieuls Sur Mer
Study site
Paris
Study site
Pessac
Study site
Pringy
Study site
Rillieux Village
Study site
Saint-Orens-de-Gameville
Study site
Seysses
Study site
Suresnes
Study site
Tiercé
About this study
The purpose of this study is to evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.
- Being tested
- Tested product : V0111 cream, Placebo
- Keywords
- Diabetic Neuropathies, Diabetes Mellitus, Diabetic Foot, Diabetes Complications
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Diabetic Foot, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tested product : V0111 creamDevice
Application twice a day during 28 days
PlaceboDevice
Application twice a day during 28 days
| Study group | Role | What they receive |
|---|---|---|
| V0111 | Experimental | Not described Receives: Device: Tested product : V0111 cream |
| Placebo | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete healing of target fissure on the heel
Comparison of the two treatment groups (verum versus placebo)
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Cracked Heel in Diabetic Patients With PolyneuropathyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Garrigue, MD, Study director, Pierre Fabre Médicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045199
- Sponsor's protocol ID
- V00111 CR 0 02
- Other IDs
- 2013-A01394-41
- Status last verified
- Apr 2015
- First submitted
- 20 Jan 2014
- Last updated
- 27 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of V0111 Cream on Open Cracked Heel in Diabetic Patients With Polyneuropathy.
- ClinicalTrials.gov ID
- NCT02045199
- Acronym / sponsor ID
- V00111 CR 0 02
- Keywords
- Diabetic Neuropathies, Diabetes Mellitus, Diabetic Foot, Diabetes Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Jan 2014 (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 evaluate the efficacy and the safety of the cream V0111 in the treatment of fissure(s) situated on the heels in diabetic patients with polyneuropathy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V0111 | Experimental | Device: Tested product : V0111 cream |
| Placebo | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diabetes mellitus with neuropathy,
- Cracked open heel with at least one fissure Grade 2,
Key exclusion criteria (6 listed)
- Open wound, skin infection, haemorrhagic crack on feet,
- Major static disorder ,
- Ulceration and history of ulceration,
- Active haemorrhagic crack,
- Hyperkeratotic disease
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 |
|---|---|---|
| Tested product : V0111 creamApplication twice a day during 28 days | Device | V0111 |
| PlaceboApplication twice a day during 28 days | Device | Placebo |
Primary outcome
Complete healing of target fissure on the heel
Time frame: Day 28
Comparison of the two treatment groups (verum versus placebo)
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 27 Apr 2015.
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.
Eric Garrigue, MD study director
Pierre Fabre Médicament
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tested product : V0111 cream in people with Open Cracked Heel in Diabetic Patients With Polyneuropathy, run by Pierre Fabre Medicament at 20 sites in 2 countries.
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 2 inclusion and 6 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 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, Belgium. 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.
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?
Complete healing of target fissure on the heel (time frame: Day 28). 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 27 Apr 2015.