Dupuytren's DiseaseNCT07505563
MiniFlo for Advanced Dupuytren's Disease
A study testing MiniFlo in people with Dupuytren's Disease, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The aim of this study is to investigate the potential use of the MiniFlo (CitiEffe) progressive distraction external fixator in the treatment of advanced Dupuytren's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren's Disease
- What is being tested?
- MiniFlo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 26 Aug 2014to 12 May 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dupuytren's disease
- Age ≥ 18 years
- Informed consent
Who cannot join
- Age < 18 years
- Pregnancy
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Stage III-IV Dupuytren's Disease With the MiniFlo External Fixator
The aim of this study is to investigate the potential use of the MiniFlo (CitiEffe) progressive distraction external fixator in the treatment of advanced Dupuytren's disease.
- Conditions
- Dupuytren's Disease
- Being tested
- MiniFlo
- Medical subject headings
- Dupuytren Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiniFloDevice
MiniFlo distraction for the restoration of finger extension
| Study group | Role | What they receive |
|---|---|---|
| Advanced-stage Dupuytren's disease | Experimental | Stage 3-4 Dupuytren's disease Receives: Device: MiniFlo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension deficit angle (degree)
Evaluation of extension deficit angle of fingers affected before and after the treatment. Min 0° (no deficit), Max 180° (high stage disease)
Measured: 12 months
Secondary outcomes (2)
Collagenase adverse effects
Assessment of potential adverse effects related to the use of collagenase
Measured: 12 months
NRS scale
Evaluation of pain before and after the treatment. Min 0 (no pain), Max 10 (maximum pain)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start26 Aug 2014
- Primary completion31 Dec 2015
- Study completion12 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dupuytren's DiseaseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Corain, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505563
- Sponsor's protocol ID
- Miniflo-ITA14
- Other IDs
- 235CESC
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Stage III-IV Dupuytren's Disease With the MiniFlo External Fixator
- ClinicalTrials.gov ID
- NCT07505563
- Acronym / sponsor ID
- Miniflo-ITA14
- Conditions
- Dupuytren's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 26 Aug 2014 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 1 Apr 2026 (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.
The aim of this study is to investigate the potential use of the MiniFlo (CitiEffe) progressive distraction external fixator in the treatment of advanced Dupuytren's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced-stage Dupuytren's disease | Experimental | Device: MiniFloStage 3-4 Dupuytren's disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dupuytren's disease
- Age ≥ 18 years
- Informed consent
Key exclusion criteria (3 listed)
- Age < 18 years
- Pregnancy
- Withdrawal of informed consent
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 |
|---|---|---|
| MiniFloMiniFlo distraction for the restoration of finger extension | Device | Advanced-stage Dupuytren's disease |
Primary outcome
Extension deficit angle (degree)
Time frame: 12 months
Evaluation of extension deficit angle of fingers affected before and after the treatment. Min 0° (no deficit), Max 180° (high stage disease)
2 secondary outcomes
Collagenase adverse effects
Time frame: 12 months
NRS scale
Time frame: 12 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 1 Apr 2026.
- 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?
A study testing MiniFlo in people with Dupuytren's Disease, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 3 inclusion and 3 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 1 Apr 2026. 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 Italy. 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?
Extension deficit angle (degree) (time frame: 12 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 1 Apr 2026.