NCT05440240 Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture
| NCT ID | NCT05440240 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Regionshospitalet Silkeborg |
| Condition | Dupuytren Contracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-01-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 400 participants in total. It began in 2023-01-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.
Eligibility Criteria
Sufficient correction of metacarpophalangeal (MCP) joint during the PNF treatment, defined as \<20° passive extension deficit (PED), is a prerequisite for inclusion. Inclusion Criteria: * Dupuytren contracture (DC) of ≥ 20° PED in MCP joint measured with a goniometer * DC of either II-V finger * Well-defined/palpable cord Exclusion Criteria: * Legally incapacitated * Previous study inclusion with another finger ray * Isolated proximal interphalangeal (PIP) or distal interphalangeal (DIP) joint contracture, defined as MCP joint contracture \< 20° PED regardless of the deficit in the PIP or DIP joint * Previous hand surgery of the affected finger for any reason * Known allergy to the study medication * Anticoagulant therapy (Acetylsalicylic acid is NOT an exclusion criterion) * Pregnant or lactation * Insulin dependent diabetes mellitus * Ongoing systemic infection or local infection at the site of the procedure * Rheumatoid arthritis * Amyloidosis or mucopolysaccharidosis * Unable to communicate, cooperate or participate in follow-up
Contact & Investigator
Jeppe Lange, MD, PhD
STUDY DIRECTOR
Regionshospitalet Horsens
Frequently Asked Questions
Who can join the NCT05440240 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 99 Years, studying Dupuytren Contracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05440240 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05440240 currently recruiting?
Yes, NCT05440240 is actively recruiting participants. Contact the research team at lather@rm.dk for enrollment information.
Where is the NCT05440240 trial being conducted?
This trial is being conducted at Silkeborg, Denmark.
Who is sponsoring the NCT05440240 clinical trial?
NCT05440240 is sponsored by Regionshospitalet Silkeborg. The principal investigator is Jeppe Lange, MD, PhD at Regionshospitalet Horsens. The trial plans to enroll 400 participants.