| 1 |
NCT03192020 |
Recruiting |
Trial Comparing Treatment Strategies in Dupuytren's Contracture |
|
- Procedure: Percutaneous needle fasciotomy
- Drug: Collagenase Clostridium Histolyticum 2.9 MG/ML [Xiaflex]
- Procedure: Limited fasciectomy
|
Interventional |
Phase 4 |
- University of Tampere
- Central Hospital of Central Finland
- Helsinki University Central Hospital
- (and 7 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Rate of success
- Entrust of the treatment
- QuickDASH
- (and 19 more...)
|
278 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT03192020 |
R17022M |
DETECT |
September 15, 2017 |
December 31, 2020 |
December 31, 2020 |
June 19, 2017 |
October 30, 2017 |
|
- Central Hospital of Central Finland
Jyväskylä, Keski-Suomi, Finland - Hatanpää Hospital
Tampere, Pirkanmaa, Finland - Tampere University Hospital
Tampere, Pirkanmaa, Finland - (and 4 more...)
|
| 2 |
NCT01715467 |
Completed |
CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The primary objective is to collect real-world data regarding patient reported outcomes of the 3 primary treatment modalities in patients with Dupuytren's contracture.
- Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes.
|
162 |
All |
18 Years and older (Adult, Senior) |
NCT01715467 |
AUX-CC-901 |
CORRECT |
September 2012 |
October 2014 |
October 2014 |
October 29, 2012 |
June 16, 2015 |
|
- Raven Orthopaedics, Inc.
Burbank, California, United States - Core Orthopaedic Medical Center
Encinitas, California, United States - Torrey Pines Orthopaedic Medical Group
La Jolla, California, United States - (and 24 more...)
|
| 3 |
NCT01588353 |
Completed
Has Results |
Collagenase Option for Reduction of Dupuytren's Contracture in Japan |
|
- Drug: Collagenase Clostridium Histolyticum
|
Interventional |
Phase 3 |
- Asahi Kasei Pharma Corporation
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Percentage of Participants That Were Successfully Treated With a "Successful Reduction in Contracture to 5°or Less"
- Clinical Improvement After the Last Injection
- Percent Reduction From Baseline Contracture After the Last Injection
- (and 2 more...)
|
104 |
All |
20 Years and older (Adult, Senior) |
NCT01588353 |
AK160-III-1 |
CORD-J |
May 2012 |
January 2014 |
January 2014 |
April 30, 2012 |
March 21, 2017 |
February 14, 2017 |
- Aichi, Japan
- Aomori, Japan
- Chiba, Japan
- (and 17 more...)
|
| 4 |
NCT01674634 |
Completed
Has Results |
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures |
|
- Biological: XIAFLEX / XIAPEX
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Total Fixed Flexion
- Change From Baseline in Total Range of Motion
- Clinical Success
- (and 7 more...)
|
715 |
All |
18 Years and older (Adult, Senior) |
NCT01674634 |
AUX-CC-867 |
|
September 2012 |
July 2013 |
July 2013 |
August 29, 2012 |
October 5, 2017 |
February 20, 2015 |
- HOPE Research Institute
Phoenix, Arizona, United States - Tucson Orthopaedic Institute
Tucson, Arizona, United States - CORE Orthopaedic Medical Center
Encinitas, California, United States - (and 22 more...)
|
| 5 |
NCT01407068 |
Completed
Has Results |
Administration of Two Injections for Multiple Dupuytren's Contractures |
|
- Biological: AA4500 collagenase clostridium histolyticum
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Total Fixed Flexion
- Change in Total Range of Motion
- Subject Satisfaction With Treatment
- (and 2 more...)
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT01407068 |
AUX-CC-864 |
|
September 2011 |
February 2012 |
February 2012 |
August 1, 2011 |
October 5, 2017 |
February 20, 2015 |
- Tucson Orthopaedic Institute
Tucson, Arizona, United States - The Indiana Hand Center
Indianapolis, Indiana, United States - Department of Orthopaedics SUNY-Stony Brook
Stony Brook, New York, United States - (and 5 more...)
|
| 6 |
NCT01265420 |
Completed
Has Results |
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb |
|
- Biological: Injectable clostridial collagenase
|
Interventional |
Phase 4 |
- Indiana Hand to Shoulder Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)
|
7 |
All |
18 Years and older (Adult, Senior) |
NCT01265420 |
IHtSC-Thumb 101 |
|
December 2010 |
February 2014 |
February 2014 |
December 23, 2010 |
April 30, 2015 |
April 9, 2015 |
- Indiana Hand to Shoulder Center
Indianaplis, Indiana, United States
|
| 7 |
NCT01538017 |
Completed |
Injectable Collagenase and Percutaneous Needle Fasciotomy for Dupuytren's Contracture |
|
- Drug: Xiapex
- Procedure: Percutaneous needle fasciotomy
|
Interventional |
Not Applicable |
- Jeppe Lange, MD
- Regionshospitalet Silkeborg
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
50 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT01538017 |
M-20110233 |
|
February 2012 |
October 2016 |
October 2016 |
February 23, 2012 |
October 4, 2016 |
|
- Center for Planned surgery - Regionalhospital Silkeborg
Silkeborg, Denmark
|
| 8 |
NCT00565019 |
Completed |
Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture |
|
- Drug: Triamcinolone Acetonide
|
Interventional |
Phase 3 |
- Sunnybrook Health Sciences Centre
- Canadian Society of Plastic Surgeons
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary endpoint of this study is the angle of contracture of the affected fingers (how bent the fingers are before and after the two treatments).
|
51 |
All |
18 Years and older (Adult, Senior) |
NCT00565019 |
DUPTRNS_STRD_RCT |
|
November 2007 |
August 2011 |
June 2013 |
November 29, 2007 |
December 13, 2013 |
|
- Sunnybrook Health Sciences Centre, Division of Plastic Surgery
Toronto, Ontario, Canada
|
| 9 |
NCT00528606 |
Completed
Has Results |
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture |
|
- Biological: collagenase clostridium histolyticum
- Biological: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection
- Clinical Improvement After the Last Injection
- Percent Reduction From Baseline Contracture After the Last Injection
- (and 6 more...)
|
308 |
All |
18 Years and older (Adult, Senior) |
NCT00528606 |
AUX-CC-857 |
CORD-I |
August 2007 |
April 2008 |
April 2008 |
September 12, 2007 |
December 2, 2017 |
October 22, 2010 |
- 100 UCLA Medical Plaza, Suite 305
Los Angeles, California, United States - Hand Surgery Clinic
Palo Alto, California, United States - Hand Surgery Associates, PC
Denver, Colorado, United States - (and 12 more...)
|
| 10 |
NCT00528931 |
Completed
Has Results |
A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture |
|
- Biological: collagenase clostridium histolyticum
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500
- Clinical Success
- Clinical Improvement
- (and 2 more...)
|
16 |
All |
18 Years and older (Adult, Senior) |
NCT00528931 |
AUX-CC-855 |
|
September 2007 |
December 2007 |
March 2008 |
September 12, 2007 |
October 5, 2017 |
August 20, 2012 |
- Providence Clinical Research
Burbank, California, United States
|
| 11 |
NCT01444729 |
Completed |
Post Approval Commitment Study |
|
- Drug: Xiapex
- Procedure: surgery
|
Observational |
|
|
Industry |
- Observational Model: Other
- Time Perspective: Prospective
|
- clinical treatment success as assessed by goniometry
- treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires
- Treatment option as determined by treating physician in consultation with patient
|
305 |
All |
18 Years and older (Adult, Senior) |
NCT01444729 |
B1531005 |
|
March 2012 |
November 2015 |
November 2015 |
October 3, 2011 |
October 26, 2017 |
|
- Auxilium Investigational Site
Bergen, Norway - Auxilium Investigational Site
Drammen, Norway - Auxilium Investigational Site
Malaga, Andalucia, Spain - (and 4 more...)
|
| 12 |
NCT02476461 |
Recruiting |
Prospective Randomized Trial Between Needle Fasciotomy and Xiapex for Dupuytrens Contracture |
|
- Drug: xiapex
- Procedure: percutaneous needle fasciotomy
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- contracture size (degrees)
- contracture size
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT02476461 |
1234 |
PNFvsxiapex |
April 2015 |
April 2016 |
January 2021 |
June 19, 2015 |
June 19, 2015 |
|
- Oslo Universitetssykehus
Oslo, Norway
|
| 13 |
NCT03031080 |
Active, not recruiting |
BOND Study: the Benefit Of Night Splinting in Dupuytrens' |
|
- Device: Thermoplastic Hand Splint
|
Interventional |
Not Applicable |
- Royal Liverpool and Broadgreen University Hospitals NHS Trust
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Range of motion
- PEM Questionnaire
- URAM Questionnaire
|
60 |
All |
Child, Adult, Senior |
NCT03031080 |
5396 |
BOND |
June 1, 2017 |
December 31, 2018 |
June 30, 2019 |
January 25, 2017 |
April 11, 2018 |
|
- Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool, Merseyside, United Kingdom
|
| 14 |
NCT03155854 |
Recruiting |
The Effects of Prophylactic Limited Palmar Fasciectomy on Surgical Outcomes and Scarring |
|
- Procedure: Pretendinous cord excision
- Procedure: Division/manipulation of the cord
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Scar Progression as measured by the Vancouver Scar Scale
- Change in Scar Progression as measured by the Patient and Observer Scar Assessment Scale
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT03155854 |
15-008280 |
|
September 2016 |
September 2018 |
September 2018 |
May 16, 2017 |
May 16, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 15 |
NCT01229436 |
Completed
Has Results |
Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) |
|
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Total Passive Extension Deficit (TPED) at Baseline for First Injection
- Total Passive Extension Deficit (TPED) at Baseline for Second Injection
- Total Passive Extension Deficit (TPED) at Baseline for Third Injection
- (and 29 more...)
|
254 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01229436 |
B1531002 |
POINT X |
December 2010 |
October 2012 |
October 2012 |
October 27, 2010 |
March 17, 2014 |
March 17, 2014 |
- Pfizer Investigational Site
Copenhagen, Denmark - Pfizer Investigational Site
Silkeborg, Denmark - Pfizer Investigational Site
Montpellier cedex 5, France - (and 25 more...)
|
| 16 |
NCT03106519 |
Recruiting |
Liposome Bupivacaine for WRIST Blocks |
- Dupuytren's Contracture of the Hand (Viking's Disease)
|
- Drug: Liposome bupivacaine + bupivacaine
|
Interventional |
Phase 2 |
- Admir Hadzic, M.D., Ph.D.
- Pacira Pharmaceuticals, Inc
- New York School of Regional Anesthesia
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in current pain over the first postoperative week
- Change in worst pain over the first postoperative week
- Change in ability to use hand
- (and 4 more...)
|
34 |
All |
18 Years to 85 Years (Adult, Senior) |
NCT03106519 |
1601 |
|
January 2, 2017 |
June 28, 2017 |
October 31, 2017 |
April 10, 2017 |
September 28, 2017 |
|
- Ziekenhuis Oost-Limburg
Genk, Belgium
|
| 17 |
NCT03331926 |
Active, not recruiting |
Collagenase is a Common Treatment of MCP and PIP Joint Contractures in Dupuytrens Disease |
|
|
Observational |
|
- Line Jensen
- Horsens Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Change in extension deficit from baseline to FU in MCP and PIP joints after treatment
|
199 |
All |
18 Years and older (Adult, Senior) |
NCT03331926 |
XIAPEX FOLLOWUP |
|
January 1, 2017 |
May 31, 2017 |
December 2017 |
November 6, 2017 |
November 6, 2017 |
|
|
| 18 |
NCT02647619 |
Active, not recruiting |
Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF |
|
- Drug: Xiapex
- Procedure: Needle aponeurotomy
|
Interventional |
Phase 4 |
- University Hospital, Akershus
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction in Total Passive Extension Deficit
- Quick Dash (Disabilities of the shoulder and Hand)
- EQ5D (Euroqol 5 Dimensions)
- (and 7 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT02647619 |
2639063
2013-001221-13 |
|
October 2013 |
November 2021 |
November 2021 |
January 6, 2016 |
January 12, 2018 |
|
- Akershus University Hospital
Oslo, Akershus, Norway
|
| 19 |
NCT01450397 |
Completed
Has Results |
MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex |
|
|
Interventional |
Phase 4 |
- Hospital for Special Surgery, New York
- Auxilium Pharmaceuticals, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.
|
5 |
All |
35 Years and older (Adult, Senior) |
NCT01450397 |
11052 |
|
March 2011 |
January 2012 |
February 2012 |
October 12, 2011 |
April 17, 2017 |
May 15, 2014 |
- Hosptial for Special Surgery
New York, New York, United States
|
| 20 |
NCT01776892 |
Withdrawn |
Collagenase and Needle Aponeurotomy: Single Modality Versus Combination Treatment for Dupuytren's Disease |
|
- Drug: Collegenase injection
- Procedure: Needle aponeurotomy
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Degree of joint contracture post treatment
- Change in joint range of motion
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01776892 |
Dupuytren's 001 |
|
May 2013 |
March 2014 |
March 2014 |
January 28, 2013 |
April 8, 2014 |
|
- Royal Alexandra Hospital
Edmonton, Alberta, Canada
|
| 21 |
NCT01184586 |
Unknown † |
Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010) |
|
- Device: Intervention - ESWT Storz Duolith high energy
- Device: CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Score of Michigan Hand Outcome Questionnaire (MHQ) [0=poor, 100= perfect]
- DASH Score [0=perfect, no impairment, 100=worst]
- Range of motion [ROM°]
- Grip strength [JAMAR]
|
60 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01184586 |
DupuyShock-2010 |
DupuyShock |
November 2011 |
December 2012 |
December 2012 |
August 19, 2010 |
December 2, 2011 |
|
- Hannover Medical School, Plastic, Hand and Reconstructive Surgery
Hannover, Germany
|
| 22 |
NCT00931567 |
Completed |
Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing |
|
- Biological: Autologous platelets gel
- Device: Vaselitulle
|
Interventional |
Phase 2
Phase 3 |
- Centre Hospitalier Universitaire de Nice
- University Hospital, Marseille
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time duration between the operation and the complete wound healing.
- -The pain during the dressings' change using a visual scale going from 0 to 10. -The bleeding of the wound.
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT00931567 |
01-APR-07 |
|
August 2007 |
February 2010 |
February 2010 |
July 2, 2009 |
March 20, 2012 |
|
- CHU Hôpital de la Timone
Marseille, Cedex 05, France - Centre Hospitalier Universitaire de Nice Hôpital de Cimiez
Nice, France
|
| 23 |
NCT00468949 |
Completed |
Health-Related Quality of Life in Patients With Dupuytren's Disease |
|
|
Observational |
|
- Hamilton Health Sciences Corporation
- McMaster University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
51 |
All |
18 Years and older (Adult, Senior) |
NCT00468949 |
06-2713 |
|
May 2007 |
July 2011 |
July 2011 |
May 3, 2007 |
July 28, 2011 |
|
- St. Joseph's Healthcare
Hamilton, Ontario, Canada
|
| 24 |
NCT02983162 |
Enrolling by invitation |
Is wGRS Associated With DD Recurrence? |
|
|
Observational |
|
- University Medical Center Groningen
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Presence of recurrent Dupuytren disease
- Severity of Dupuytren recurrence
|
677 |
All |
18 Years and older (Adult, Senior) |
NCT02983162 |
201600670 |
|
March 10, 2017 |
May 2019 |
May 2020 |
December 6, 2016 |
October 18, 2017 |
|
- University Medical Center Groningen, dept Plastic Surgery
Groningen, Netherlands
|
| 25 |
NCT00014742 |
Completed |
Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease |
|
|
Interventional |
Phase 3 |
- State University of New York
- FDA Office of Orphan Products Development
|
Other |
- Allocation: Randomized
- Primary Purpose: Treatment
|
|
72 |
All |
18 Years and older (Adult, Senior) |
NCT00014742 |
199/15764
SUNY-SB-FDR001437 |
|
|
|
April 2004 |
April 11, 2001 |
March 25, 2015 |
|
|
| 26 |
NCT00004409 |
Completed |
Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease |
|
|
Interventional |
Phase 2 |
- State University of New York
- FDA Office of Orphan Products Development
|
Other |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Treatment
|
|
36 |
All |
18 Years and older (Adult, Senior) |
NCT00004409 |
199/13297
SUNY-SB-FDR001373
DUPY-101
DUPY-202
SUNY-SB-431-1007A
SUNY-SB-431-8804B
SUNY-SB-431-X2020 |
|
August 1995 |
|
April 2004 |
October 19, 1999 |
March 25, 2015 |
|
- Stanford University Hospital
Palo Alto, California, United States - State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
|
| 27 |
NCT01567397 |
Completed |
Registry of Dupuytren's Contracture Treatment Outcomes |
|
|
Observational |
|
- Technische Universität Dresden
- GWT-TUD GmbH
- Pfizer
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
87 |
All |
18 Years to 100 Years (Adult, Senior) |
NCT01567397 |
ReDuCTO ID 7090 |
ReDuCTO |
December 2011 |
April 2013 |
April 2013 |
March 30, 2012 |
December 22, 2016 |
|
- Prof. Dr. Max Haerle
Markgröningen, Germany - Prof. Dr. Riccardo Giunta
Munich, Germany - Several undisclosed sites
Various cities, Germany - Dr. Joerg Witthaut
Vogtareuth, Germany
|
| 28 |
NCT00575458 |
Completed |
Splinting for Dupuytren's Contracture Release |
|
|
Observational |
|
- Massachusetts General Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00575458 |
2005p002466 |
|
June 2005 |
June 2010 |
June 2010 |
December 18, 2007 |
November 16, 2010 |
|
- Massachusetts General Hospital
Boston, Massachusetts, United States
|
| 29 |
NCT01226121 |
Terminated
Has Results |
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture |
|
- Biological: Clostridial collagenase injectable
|
Interventional |
Phase 4 |
- Indiana Hand to Shoulder Center
- Stony Brook University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
- Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
|
37 |
All |
18 Years and older (Adult, Senior) |
NCT01226121 |
IHtSC-Delay 101 |
|
December 2010 |
December 2012 |
December 2012 |
October 21, 2010 |
June 16, 2014 |
June 16, 2014 |
- Indiana Hand to Shoulder Center
Indianaplis, Indiana, United States - Stony Brook University
Stony Brook, New York, United States
|
| 30 |
NCT03000114 |
Recruiting |
Collagenase Injection vs Percutaneous Needle Aponeurotomy for Dupuytren's Disease |
- Dupuytren Contracture
- Dupuytren's Disease of Finger
|
- Procedure: Percutaneous Needle Aponeurotomy
- Drug: XIAFLEX
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Contracture Recurrence
- Patient Satisfaction
- Complications
|
334 |
All |
18 Years and older (Adult, Senior) |
NCT03000114 |
REB15-2463 |
|
January 2016 |
January 2021 |
January 2021 |
December 21, 2016 |
December 21, 2016 |
|
- University of Calgary
Calgary, Alberta, Canada
|
| 31 |
NCT01923103 |
Active, not recruiting |
Natural Disease Progress of Dupuytren Disease |
- Dupuytren Contracture
- Disease Progression
|
|
Observational |
|
- University Medical Center Groningen
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The natural course of progression of DD; change in severity of disease from baseline to measurement point
- Risk factors and their change over time
- change in hand function
- Occurence of recurrent disease
|
261 |
All |
18 Years and older (Adult, Senior) |
NCT01923103 |
NDPDD |
DD |
May 2012 |
July 2022 |
July 2022 |
August 14, 2013 |
October 18, 2017 |
|
- University Medical Center Groningen
Groningen, Netherlands
|
| 32 |
NCT01876498 |
Completed |
Registry of Patient With M. Dupuytren and Validation of the Brief MHQ |
- Dupuytren Contracture
- Collagen Shrinkage
- CRF
|
- Procedure: Xiaflex surgery
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Brief Michigan Hand Questionnaire
- Joint mobility
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT01876498 |
Brief MHQ1
Dupuytren 1 |
|
August 2013 |
July 2015 |
July 2015 |
June 12, 2013 |
August 22, 2016 |
|
- Schulthess Klinik
Zurich, Switzerland
|
| 33 |
NCT01498640 |
Completed
Has Results |
Retreatment of Recurrent Dupuytren's Contractures |
|
- Biological: Collagenase clostridium histolyticum
|
Interventional |
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Success
- Percent Change From Baseline in Degree of Contracture
- Change in Range of Motion
- (and 3 more...)
|
52 |
All |
18 Years and older (Adult, Senior) |
NCT01498640 |
AUX-CC-862 |
|
March 2012 |
October 2013 |
October 2013 |
December 23, 2011 |
October 5, 2017 |
February 20, 2015 |
- HOPE Research Institute
Phoenix, Arizona, United States - Rockford Orthopedic Associates
Rockford, Illinois, United States - The Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States - (and 10 more...)
|
| 34 |
NCT01446432 |
Unknown † |
Validation of Two New Questionnaires for Dupuytren's Disease |
|
|
Observational |
|
- Robert Hotchkiss
- Auxilium Pharmaceuticals, Inc.
- Hospital for Special Surgery, New York
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- QuickDASH (Disability of the Arm, Shoulder, and Hand)
|
80 |
All |
35 Years and older (Adult, Senior) |
NCT01446432 |
11011 |
|
February 2011 |
December 2015 |
December 2015 |
October 5, 2011 |
April 3, 2015 |
|
- Hospital For Special Surgery
New York, New York, United States
|
| 35 |
NCT00260429 |
Completed
Has Results |
Collagenase in the Treatment of Dupuytrens Disease |
|
- Biological: collagenase clostridium histolyticum
|
Interventional |
Phase 3 |
- Stony Brook University
- Biospecifics Technologies Corp.
- Endo Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Primary Outcome Measure is Reduction of Flexion Contracture of the Primary Joint.
- Percent Reduction From Baseline Contracture After the Last Injection
- Percent Change From Baseline Range of Motion After the Last Injection
- (and 4 more...)
|
38 |
All |
18 Years and older (Adult, Senior) |
NCT00260429 |
DUPY 303 |
|
June 2003 |
August 2005 |
April 2008 |
December 1, 2005 |
December 9, 2010 |
December 9, 2010 |
- Stony Brook University Hospital and Mediacl Center
Stony Brook, New York, United States
|
| 36 |
NCT03180957 |
Recruiting |
Repurposing Anti-TNF for Treating Dupuytren's Disease |
|
- Drug: Adalimumab
- Drug: Saline
|
Interventional |
Phase 2 |
- University of Oxford
- Department of Health, United Kingdom
- Wellcome Trust
- 180 Therapeutics LP
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Dose Response: expression of mRNA for α-SMA
- Early Disease: change in nodule hardness between baseline at 12 months
- Dose Response: expression of mRNA for COL-1A1, COL-3A1, cadherin 11
- (and 11 more...)
|
178 |
All |
18 Years and older (Adult, Senior) |
NCT03180957 |
11069
HICF-R8-433
2015-001780-40
ISRCTN27786905
15/SC/0259
CTU0028 |
RIDD |
March 2, 2016 |
December 2019 |
June 2020 |
June 8, 2017 |
February 6, 2018 |
|
- Queen Victoria Hospital NHS Foundation Trust
East Grinstead, United Kingdom - NHS Lothian
Edinburgh, United Kingdom - Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
|
| 37 |
NCT00954746 |
Completed |
Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859 |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Contracture Measurements
- Immunogenicity, concomitant medications, medical history, and adverse events
|
645 |
All |
18 Years and older (Adult, Senior) |
NCT00954746 |
AUX-CC-860 |
|
July 2009 |
May 2013 |
May 2013 |
August 7, 2009 |
June 16, 2015 |
|
- Hope Research Institute
Phoenix, Arizona, United States - Tucson Orthopedic Institute, P.C.
Tucson, Arizona, United States - Providence Clinical Research
Burbank, California, United States - (and 36 more...)
|
| 38 |
NCT03406338 |
Enrolling by invitation |
Fasciectomy vs Collagenase Injection in Recurrent Dupuytren Disease |
- Dupuytren Disease of Finger
|
- Procedure: Fasciectomy
- Drug: Collagenase Clostridium Histolyticum
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Total active extension deficit (metacarpophalangeal plus proximal interphalangeal joints)
- Proportion of patients with worsening in total active extension deficit ≥20 degrees
- 11-item disabilities of the arm, shoulder and hand (QuickDASH) score
- (and 9 more...)
|
56 |
All |
18 Years and older (Adult, Senior) |
NCT03406338 |
Hlm_DC |
|
March 20, 2018 |
May 31, 2021 |
May 31, 2024 |
January 23, 2018 |
April 5, 2018 |
|
- Department of Orthopedics Hässleholm-Kristianstad
Hässleholm, Sweden
|
| 39 |
NCT02725528 |
Recruiting |
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's |
|
- Drug: collagenase injection
- Procedure: limited palmar fasciectomy
|
Interventional |
Phase 3 |
- McMaster University
- The Physicians' Services Incorporated Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- health-related quality of life (HRQL) using the Michigan Hand Outcomes Questionnaire (MHQ)
- HRQL measured with the Health Utility Index Mark 3 (HUI3) of Health)
- HRQL measured with the Unité Rhumatologique des Affections de la Main (URAM)
- (and 5 more...)
|
128 |
All |
18 Years and older (Adult, Senior) |
NCT02725528 |
PSI 2016-03 |
EXTEND |
July 8, 2017 |
July 2018 |
November 2018 |
April 1, 2016 |
January 4, 2018 |
|
- Hamilton Health Sciences
Hamilton, Ontario, Canada - St. Joseph's Healthcare / McMaster University
Hamilton, Ontario, Canada - St. Joseph's Hospital
Hamilton, Ontario, Canada - (and 7 more...)
|
| 40 |
NCT02474576 |
Active, not recruiting |
Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease |
|
- Procedure: Percutaneous aponeurotomy
|
Interventional |
Not Applicable |
- Groupe Hospitalier Diaconesses Croix Saint-Simon
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Frequency of local relapse at 24 months
- Primary success rate of aponeurotomy
- Frequency of local relapse at 12 months
- (and 3 more...)
|
130 |
All |
18 Years and older (Adult, Senior) |
NCT02474576 |
MMN_2015-1 |
APADUP |
September 2015 |
April 2019 |
April 2022 |
June 17, 2015 |
October 12, 2017 |
|
- Diaconesses Croix Saint-Simon Hospital Group
Paris, France
|
| 41 |
NCT02301078 |
Recruiting |
Short-term Function and Pain After Treatment for Dupuytren's Disease |
|
- Procedure: Percutaneous Needle Aponeurotomy
- Drug: Collagenase clostridium histolyticum
|
Observational |
|
- Sunnybrook Health Sciences Centre
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Brief Michigan Hand Questionnaire (brief MHQ)
- Unite Rhumatologique des Affections de la Main (URAM) scale
- Daily Pain and Function Scales
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT02301078 |
Pain and Function - PNA vs CCH |
|
July 2014 |
October 2017 |
November 2017 |
November 25, 2014 |
December 6, 2016 |
|
- Sunnybrook Health Sciences Centre, Division of Plastic and Reconstructive Surgery
Toronto, Ontario, Canada
|
| 42 |
NCT02193828 |
Completed
Has Results |
Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules |
|
- Biological: Collagenase clostridium histolyticum
- Biological: Placebo
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements
- Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound
- Change From Baseline in Consistency of the Treated Nodules at Day 57
- (and 5 more...)
|
76 |
All |
18 Years and older (Adult, Senior) |
NCT02193828 |
AUX-CC-750 |
|
July 2014 |
December 2014 |
December 2014 |
July 18, 2014 |
October 5, 2017 |
July 7, 2015 |
- Tucson Orthopaedic Institute
Tucson, Arizona, United States - CORE Orthopaedic Medical Center
Encinitas, California, United States - Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States - (and 8 more...)
|
| 43 |
NCT00533273 |
Completed
Has Results |
Non-US Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease |
- Advanced Dupuytren's Disease
|
- Biological: collagenase clostridium histolyticum
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Reduction in Primary Joint Contracture to 5° or Less
- Clinical Improvement in Primary Joint After the Last Injection
- Percent Reduction From Baseline Contracture of Primary Joint After the Last Injection
- (and 15 more...)
|
66 |
All |
18 Years and older (Adult, Senior) |
NCT00533273 |
AUX CC 859 |
CORD-II |
August 2007 |
September 2008 |
September 2008 |
September 21, 2007 |
December 2, 2017 |
October 22, 2010 |
- Rivercity Research
Auchenflower, Queensland, Australia - Brisbane Hand & Upper Limb Clinic
Brisbane, Queensland, Australia - Caboolture Clinical Research Centre
Caboolture, Queensland, Australia - (and 4 more...)
|
| 44 |
NCT00528840 |
Completed
Has Results |
Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease |
- Advanced Dupuytren's Disease
|
- Biological: collagenase clostridium histolyticum
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction in Contracture to 5° or Less
- Clinical Improvement After the Last Injection
- Percent Reduction From Baseline Contracture After the Last Injection
- (and 6 more...)
|
201 |
All |
18 Years and older (Adult, Senior) |
NCT00528840 |
AUX-CC-856 |
JOINT-I |
October 2007 |
October 2008 |
October 2008 |
September 12, 2007 |
December 2, 2017 |
October 22, 2010 |
- Hope Research Institute
Phoenix, Arizona, United States - Tucson Orthopedic Institute, P.C.
Tucson, Arizona, United States - Providence Clinical Research
Burbank, California, United States - (and 11 more...)
|
| 45 |
NCT00528424 |
Completed
Has Results |
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease |
- Advanced Dupuytren's Disease
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Reduction in Contracture to 5° or Less
- Clinical Improvement After the Last Injection
- Percent Reduction From Baseline Contracture After the Last Injection
- (and 6 more...)
|
286 |
All |
18 Years and older (Adult, Senior) |
NCT00528424 |
AUX-CC-858 |
|
December 2007 |
November 2008 |
November 2008 |
September 12, 2007 |
December 2, 2017 |
October 22, 2010 |
- 100 UCLA Medical Plaza, Suite 305
Los Angeles, California, United States - Hand Surgery Clinic
Palo Alto, California, United States - Hand Surgery Associates, PC
Denver, Colorado, United States - (and 12 more...)
|
| 46 |
NCT03111186 |
Not yet recruiting |
Ibuprofen Plus Acetaminophen Versus Oxycodone Alone After Hand Surgery |
- Carpal Tunnel Syndrome
- Dupuytren Contracture
- Trigger Digit
- (and 2 more...)
|
- Drug: Oxycodone Hcl 5Mg
- Drug: Ibuprofen 400 mg
- Drug: Acetaminophen 650 mg
|
Interventional |
Phase 2 |
- University of Southern California
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- change in VAS pain scale
- change in Brief Pain Index
- change in pain diary
|
168 |
All |
18 Years and older (Adult, Senior) |
NCT03111186 |
HS-15-00706 |
|
June 5, 2017 |
October 31, 2017 |
December 31, 2017 |
April 12, 2017 |
May 11, 2017 |
|
- Keck School of Medicine of the University of Southern California
Los Angeles, California, United States
|
| 47 |
NCT02294890 |
Unknown † |
Knee Stiffness in Fibrosis Diathesis |
- Knee Replacement Arthroplasty
- Fibrosis
- Dupuytren's Disease
|
- Procedure: Total knee arthroplasty
|
Observational |
|
- University Hospital Pellenberg
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Range of movement of the operated knee at 12 months postoperatively
- Additional procedures/interventions to gain motion
- - Increase of contracture or appearance of the nodules and contractures in the hand after the knee surgery.
- KSS score for knee function
|
60 |
All |
50 Years and older (Adult, Senior) |
NCT02294890 |
UHPellenberg |
|
January 2015 |
March 2015 |
April 2015 |
November 19, 2014 |
November 19, 2014 |
|
|
| 48 |
NCT03407820 |
Not yet recruiting |
Different Sutures in Hand Surgery |
- All Minor Hand Surgery Including
- Carpal Tunnel Syndrome
- Trigger Finger
- (and 3 more...)
|
- Procedure: Absorbable Chromic gut sutures
- Procedure: Non-absorbable Nylon sutures
|
Interventional |
Not Applicable |
- University of Texas at Austin
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Treatment satisfaction measured on an 11-point ordinal scale
- Factors associated with wound concerns within one month of surgery
- Factors associated with pain intensity (11 point ordinal scale) within one month of surgery
- (and 3 more...)
|
140 |
All |
18 Years to 89 Years (Adult, Senior) |
NCT03407820 |
2017-11-0021 |
|
January 2018 |
July 2018 |
October 2018 |
January 23, 2018 |
January 24, 2018 |
|
|
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