NCT07505563

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 26, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2016

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

March 9, 2026

Last Update Submit

March 27, 2026

Conditions

Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (2)

  • Collagenase adverse effects

    12 months

  • NRS scale

    12 months

Study Arms (1)

Advanced-stage Dupuytren's disease

EXPERIMENTAL

Stage 3-4 Dupuytren's disease

Device: MiniFlo

Interventions

MiniFloDEVICE

MiniFlo distraction for the restoration of finger extension

Advanced-stage Dupuytren's disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Verona

Verona, VERONA, 37126, Italy

Location

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 9, 2026

First Posted

April 1, 2026

Study Start

August 26, 2014

Primary Completion

December 31, 2015

Study Completion

May 12, 2016

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)