Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 235CESC | Registry Identifier | Internal protocol of University Hospital of Verona |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced-stage Dupuytren's disease | Experimental | Stage 3-4 Dupuytren's disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniFlo | Device | MiniFlo distraction for the restoration of finger extension |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Collagenase adverse effects | Assessment of potential adverse effects related to the use of collagenase | 12 months |
| NRS scale | Evaluation of pain before and after the treatment. Min 0 (no pain), Max 10 (maximum pain) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Verona | Verona | VERONA | 37126 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2026 | Mar 19, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2014 | Mar 24, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |