Dupuytren Disease of FingerPhase 4NCT03406338
Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease
A Phase 4 study testing Fasciectomy and Collagenase Clostridium Histolyticum in people with Dupuytren Disease of Finger, run by Region Skane at 1 site in Sweden.
Trial summary
This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dupuytren Disease of Finger
- What is being tested?
- Fasciectomy and Collagenase Clostridium Histolyticum
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 20 Mar 2018to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.
- Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy, collagenase injections, or needle fasciotomy.
- Palpable cord in the palm and/or affected finger causing the recurrent contracture.
- No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent contracture in the past 12 months.
Who cannot join
- Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.
- Signs of nerve or vascular injury in the affected finger.
- Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger
- Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).
- Previous trauma or other surgery involving the affected finger.
- More than 2 previous surgeries, collagenase injections or needle fasciotomies in the affected finger.
- Examining surgeon deems further fasciectomy inappropriate or potentially associated with very high complication risk, for example in severe contracture and/or severe scarring after the previous surgeries and considers salvage procedures (such as amputation) as the more appropriate treatment.
- Patient refusal to participate
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopedics Hässleholm-Kristianstad
Hässleholm, SE 28125
About this study
Official title: Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial
This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.
Read the detailed description
No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for patients with recurrence. However, the procedure is associated with a high incidence of complications. Injection of Collagenase Clostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment for DD and has been shown to be a safe and effective method. Most studies regarding collagenase injection have involved first-time treatment. Efficacy of collagenase injection in patients with recurrent DD, beyond the immediate effect, has not yet been determined. This randomized trial will compare the outcome of surgical fasciectomy and collagenase injection in treating patients with finger joints contracture due to recurrent DD. The study is a single-center randomized controlled trial. Patients referred to an orthopedic department are screened for eligibility. The inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy, collagenase injection or needle fasciotomy, a passive extension deficit ≥30 degrees in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint in a previously treated finger, and a palpable cord believed to cause the recurrent contracture. A total of 56 patients will be randomized (computer-generated randomization list, stratified according to type of previous treatment and affected finger), to either surgical fasciectomy or collagenase injection. A blinded hand therapist will measure range of motion (including active and passive extension deficit) at baseline and 3 months, 12 months, 24 months and 60 months after treatment. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20 degrees in the treated finger joint at 2 years compared to 3 months. The secondary outcomes include total passive extension deficit, the 11-item disabilities of the arm, shoulder and hand (QuickDASH) score, EuroQol 5-dimensions (EQ-5D) index, cold intolerance symptom severity score, palmar pain score, pain visual analog scale (VAS) score, satisfaction VAS score, adverse events and costs.
- Conditions
- Dupuytren Disease of Finger
- Being tested
- Fasciectomy, Collagenase Clostridium Histolyticum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FasciectomyProcedure or surgery
Also called Surgery
Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary.
Collagenase Clostridium HistolyticumDrug
Also called Non-surgical treatment
Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Surgical fasciectomy | Active comparator | Fasciectomy according to usual care (surgery), implying excision of Dupuytren's cords and tissues to release the finger joint contractures Receives: Procedure: Fasciectomy |
| Collagenase Clostridium Histolyticum | Experimental | Injection of 0.8 mg collagenase clostridium histolyticum into multiple spots in the Dupuytren cords followed by finger manipulation 1-2 days later to release the finger joint contractures Receives: Drug: Collagenase Clostridium Histolyticum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
Measured: Change from baseline to 3 months
Proportion of patients with worsening in total active extension deficit ≥20 degrees
Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
Measured: 24 months compared to 3 months
Secondary outcomes (12)
11-item disabilities of the arm, shoulder and hand (QuickDASH) score
A patient-reported outcome measure of activity limitations related to upper extremity disorders, with total score range from 0 (best) to 100 (worst)
Measured: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
EuroQoL 5-dimensions (EQ-5D) Index
Health-status and quality-of-life patient-reported measure, consists of 5 items, a single weighted score, the EQ-5D index, is calculated from the 5 dimensions, ranging from -0.594 (worst) to 1.0 (perfect health)
Measured: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Pain score
Visual analog scale of pain in the treated hand, score range from 0 (best) to 100 (worst)
Measured: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Satisfaction score
Visual analog scale of patient satisfaction with treatment outcome, score range from 0 (best) to 100 (worst)
Measured: 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Adverse events
All observed and reported adverse events will be recorded on a standard form. Serious adverse events include nerve, artery or tendon damage, deep infection, complex regional pain syndrome and any complications requiring surgery or hospital admission.
Measured: Anytime during 24 months after treatment
Costs
Total treatment cost, direct (medications, surgery, materials, visits etc) and indirect (sick leave related to the treatment)
Measured: From baseline through 24 months
Total active motion
Sum of active range of motion of metacarpophalangeal, proximal intephalangeal and distal interphalangeal joints of the treated finger
Measured: Change from baseline to 3 months, 12 months, 24 months and 60 months
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
Active extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
Measured: Change from baseline to 12 months, 24 months and 60 months
Proportion of patients with worsening in total active extension deficit ≥20 degrees
Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
Measured: 60 months compared to 3 months
Palmar pain score
2-item scale inquiring about pain in the palm and related activity limitations, total score range 0 (best) to 100 (worst)
Measured: Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Cold intolerance symptom severity score
6-item scale inquiring about symptoms of cold intolerance, total score range 4 (best) to 100 (worst)
Measured: Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
Passive extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
Measured: Change from baseline to 24 months and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start20 Mar 2018
- Primary completion1 Sep 2024
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dupuytren Disease of FingerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel Group, ratio 1:1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isam Atroshi, Region Skane
- Investigators
- Isam Atroshi, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406338
- Sponsor's protocol ID
- Hlm_DC
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2018
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nordenskjold J, Lauritzson A, Walden M, Kopylov P, Atroshi I. Surgical fasciectomy versus collagenase injection in treating recurrent Dupuytren disease: study protocol of a randomised controlled trial. BMJ Open. 2019 Feb 25;9(2):e024424. doi: 10.1136/bmjopen-2018-024424.
PubMed 30808670
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Fasciectomy Versus Collagenase Injection in Treating Recurrent Dupuytren Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03406338
- Acronym / sponsor ID
- Hlm_DC
- Conditions
- Dupuytren Disease of Finger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jan 2018 (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.
This randomized controlled trial will compare the outcome of surgery (fasciectomy) with that of local injection of Collagenase Clostridium Histolyticum in patients with recurrent finger joint contracture after previous treatment with Surgery, collagenase injection or needle fasciotomy. Half of the participants will be treated with surgery while the other half will receive collagenase injection.
Detailed description
No definitive cure for Dupuytren disease (DD) currently exists and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for patients with recurrence. However, the procedure is associated with a high incidence of complications. Injection of Collagenase Clostridium Histolyticum into Dypuytren cords causing the contracture is a non-surgical treatment for DD and has been shown to be a safe and effective method. Most studies regarding collagenase injection have involved first-time treatment. Efficacy of collagenase injection in patients with recurrent DD, beyond the immediate effect, has not yet been determined. This randomized trial will compare the outcome of surgical fasciectomy and collagenase injection in treating patients with finger joints contracture due to recurrent DD. The study is a single-center randomized controlled trial. Patients referred to an orthopedic department are screened for eligibility. The inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy, collagenase injection or needle fasciotomy, a passive extension deficit ≥30 degrees in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint in a previously treated finger, and a palpable cord believed to cause the recurrent contracture. A total of 56 patients will be randomized (computer-generated randomization list, stratified according to type of previous treatment and affected finger), to either surgical fasciectomy or collagenase injection. A blinded hand therapist will measure range of motion (including active and passive extension deficit) at baseline and 3 months, 12 months, 24 months and 60 months after treatment. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20 degrees in the treated finger joint at 2 years compared to 3 months. The secondary outcomes include total passive extension deficit, the 11-item disabilities of the arm, shoulder and hand (QuickDASH) score, EuroQol 5-dimensions (EQ-5D) index, cold intolerance symptom severity score, palmar pain score, pain visual analog scale (VAS) score, satisfaction VAS score, adverse events and costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel Group, ratio 1:1.
| Arm | Type | Receives |
|---|---|---|
| Surgical fasciectomy | Active comparator | Procedure: FasciectomyFasciectomy according to usual care (surgery), implying excision of Dupuytren's cords and tissues to release the finger joint contractures |
| Collagenase Clostridium Histolyticum | Experimental | Drug: Collagenase Clostridium HistolyticumInjection of 0.8 mg collagenase clostridium histolyticum into multiple spots in the Dupuytren cords followed by finger manipulation 1-2 days later to release the finger joint contractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Seeking treatment for recurrence of Dupuytren´s contracture in at least one finger.
- Passive extension deficit of 30 degrees or greater in the metacarpophalangeal and/or proximal interphalangeal joint in a finger previously treated with surgical fasciectomy, collagenase injections, or needle fasciotomy.
- Palpable cord in the palm and/or affected finger causing the recurrent contracture.
- No Surgery, collagenase injection or needle fasciotomy in the finger with recurrent contracture in the past 12 months.
Key exclusion criteria (8 listed)
- Medical comorbidities that constitute a contraindication for surgical fasciectomy or collagenase injection.
- Signs of nerve or vascular injury in the affected finger.
- Osteoarthritis in the metacarpophalangeal and/or proximal interphalangeal joint joint in the affected finger
- Complications after the previous treatment, such as infection or complex regional pain syndrome (CRPS).
- Previous trauma or other surgery involving the affected finger.
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 |
|---|---|---|
| FasciectomyAlso: SurgerySurgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary. | Procedure or surgery | Surgical fasciectomy |
| Collagenase Clostridium HistolyticumAlso: Non-surgical treatmentInjection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia | Drug | Collagenase Clostridium Histolyticum |
Primary outcome
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
Time frame: Change from baseline to 3 months
Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
Proportion of patients with worsening in total active extension deficit ≥20 degrees
Time frame: 24 months compared to 3 months
Extension deficit of the metacarpophalangeal and interphalangeal joints of the treated finger measured with hand-held goniometer (0 degrees indicates no extension deficit)
12 secondary outcomes
11-item disabilities of the arm, shoulder and hand (QuickDASH) score
Time frame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
EuroQoL 5-dimensions (EQ-5D) Index
Time frame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Pain score
Time frame: Change over time from from baseline, 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Satisfaction score
Time frame: 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months
Adverse events
Time frame: Anytime during 24 months after treatment
Costs
Time frame: From baseline through 24 months
Total active motion
Time frame: Change from baseline to 3 months, 12 months, 24 months and 60 months
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
Time frame: Change from baseline to 12 months, 24 months and 60 months
Proportion of patients with worsening in total active extension deficit ≥20 degrees
Time frame: 60 months compared to 3 months
Palmar pain score
Time frame: Change over time from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Cold intolerance symptom severity score
Time frame: Change from baseline to 3 weeks, 6 weeks, 3 months, 12 months, 24 months and 60 months.
Total passive extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
Time frame: Change from baseline to 24 months and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 30808670Nordenskjold J, Lauritzson A, Walden M, Kopylov P, Atroshi I. Surgical fasciectomy versus collagenase injection in treating recurrent Dupuytren disease: study protocol of a randomised controlled trial. BMJ Open. 2019 Feb 25;9(2):e024424. doi: 10.1136/bmjopen-2018-024424.
- 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.
Isam Atroshi, MD, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fasciectomy and Collagenase Clostridium Histolyticum in people with Dupuytren Disease of Finger, run by Region Skane at 1 site in Sweden.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. 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 Sweden. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints) (time frame: Change from baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03406338, which also lists 1 linked publication.
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 16 Apr 2025.