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Dupuytren's Disease clinical trials

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NCT ID: NCT04122313 Recruiting - Clinical trials for Dupuytren Contracture

Post-contracture Release Radiation for Dupuytren's Disease

Start date: May 31, 2019
Phase:
Study type: Observational

To determine if the clinical impression of clinicians, ie that patients are improving with the current treatment pathway for Dupuytren's (contracture release followed by radiation), can be substantiated with scientific evidence.

NCT ID: NCT03180957 Completed - Dupuytren's Disease Clinical Trials

Repurposing Anti-TNF for Treating Dupuytren's Disease

RIDD
Start date: March 2, 2016
Phase: Phase 2
Study type: Interventional

Dupuytren's disease is a very common condition, affecting 4% of the general UK and US population. It causes the fingers to curl irreversibly into the palm and can be extremely disabling. The disease usually starts as a small firm lump (nodule) in the palm, and in about 40% of patients advances to form cords that pull the fingers into the palm. There is no approved treatment for the early stage of disease. Once patients have established deformities, the diseased tissue can removed by surgery or cut using less invasive techniques such as a needle or an enzyme. However, recovery following surgery usually takes several months and recurrence rates with the less invasive techniques are high. The investigators have unravelled the cellular process that initiates and maintains the disease progress and identified tumour necrosis factor (TNF) as a new target for treatment. Based on these findings the investigators plan to test the effects of adalimumab, an anti-TNF drug which currently approved for use in patients with rheumatoid arthritis and other inflammatory conditions. The aim of the study is to find out whether treatment by injection with adalimumab directly into the diseased tissue will control the advance of early Dupuytren's disease better than a placebo injection with normal saline. The investigators will first carry out a small trial in up to 40 patients with established disease to determine the best dose that reduces the activity of the cells responsible for the disorder (Dose Response study). In this part patients who will be having surgery to remove their diseased tissue will receive a single injection of adalimumab into the nodule in their hand about 2 weeks before surgery. The tissue that is then removed during surgery will be analysed in the investigator's laboratories to determine the effect of the drug on the tissue. Patients will be followed for 12 weeks after surgery. In the second part of the study the investigators will assess whether the optimal dose of the drug prevents early disease advancing in 138 patients (Early Disease study). Patients who take part in the second part of the study will receive a total of 4 injections of adalimumab into the nodule in their hand at three monthly intervals. They will then be checked at 3 & 9 months after the last injection. In additional to assessing the effect of the injections on the nodule and hand function, information will also be collected to assess the cost effectiveness of the treatment.

NCT ID: NCT02725528 Completed - Dupuytren's Disease Clinical Trials

Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's

EXTEND
Start date: July 8, 2017
Phase: Phase 3
Study type: Interventional

This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms of improved quality of life and reducing recurrence of the disease without serious complications. Since collagenase injections are costly it is also important to know if this novel intervention is cost-effective from the patient, Ministry of Health and societal perspectives.

NCT ID: NCT02294890 Not yet recruiting - Fibrosis Clinical Trials

Knee Stiffness in Fibrosis Diathesis

Start date: January 2015
Phase: N/A
Study type: Observational

At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients will be checked for signs of fibrosis diathesis. This will be done by examining their hands for Dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of Dupuytren's contracture. These include family history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis. This way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and 6 months will be retrieved in the charts, the ROM at 12 months will be measured at that time. Also, additional procedures performed to increase ROM postoperatively will be retrieved from the charts (e.g. continuous passive motion, mobilization under anesthesia). Other causes for knee stiffness will have to be recorded, since these will be the most important exclusion criteria. In the patients with clear signs of finger contractures, any impression of increase of contracture over the past 12 months will be recorded.

NCT ID: NCT02193828 Completed - Dupuytren's Disease Clinical Trials

Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.

NCT ID: NCT01567397 Completed - Dupuytren's Disease Clinical Trials

Registry of Dupuytren's Contracture Treatment Outcomes

ReDuCTO
Start date: December 2011
Phase: N/A
Study type: Observational

Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.Thus, the present study aims to collect data on the - Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice - Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy) - Effectiveness (with focus on functionality) - Tolerability - Patient-related outcomes: patient satisfaction, health-related quality of life - Physician satisfaction with therapy - Resource utilization (hospital stays, drug consumption, concomitant medication etc.) - Long-term outcomes

NCT ID: NCT01498640 Completed - Dupuytren's Disease Clinical Trials

Retreatment of Recurrent Dupuytren's Contractures

Start date: March 2012
Phase: Phase 4
Study type: Interventional

The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.

NCT ID: NCT01450397 Completed - Dupuytren's Disease Clinical Trials

MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

Start date: March 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.

NCT ID: NCT01446432 Active, not recruiting - Dupuytren's Disease Clinical Trials

Validation of Two New Questionnaires for Dupuytren's Disease

Start date: February 2011
Phase: N/A
Study type: Observational

A study to validate two newly developed questionnaires for Dupuytren's Disease. The objective is to develop a patient specific outcomes tool for Dupuytren's Disease. While there are standard and validated questionnaire instruments used to measure health related quality of life and function, they do not address patient specific issues. The investigators will also pilot a treatment/disease specific satisfaction questionnaire for Xiaflex use for Dupuytren's Disease.

NCT ID: NCT01226121 Terminated - Dupuytren's Disease Clinical Trials

Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture

Start date: December 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.