MiniFlo for Advanced Dupuytren's Disease

March 27, 2026 updated by: Massimo Corain, Azienda Ospedaliera Universitaria Integrata Verona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • VERONA
      • Verona, VERONA, Italy, 37126
        • University Hospital of Verona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Dupuytren's disease
  • Age ≥ 18 years
  • Informed consent

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Withdrawal of informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Advanced-stage Dupuytren's disease
Stage 3-4 Dupuytren's disease
Device: MiniFlo
MiniFlo distraction for the restoration of finger extension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collagenase adverse effects
Time Frame: 12 months
Assessment of potential adverse effects related to the use of collagenase
12 months
NRS scale
Time Frame: 12 months
Evaluation of pain before and after the treatment. Min 0 (no pain), Max 10 (maximum pain)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2014

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

May 12, 2016

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Miniflo-ITA14
  • 235CESC (Registry Identifier: Internal protocol of University Hospital of Verona)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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