Dupuytren'Disease, thumb, first webspace, collagenase (Xiapex) injections Ziekte van Dupuytren, duim, eerste webspace, collagenase injecties
Conditions
Interventions
For each patient the study will have 2 phases. The first phase will be an open label treatment phase (up to 3 months in duration) while the second phase will be a 6 month follow up phase.
A maximum o
Sponsors
Prof P.M.N.Werker
P.O.Box 30001
9700RB Groningen
+31503618840
p.m.n.werker@umcg.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age and ≤ 75 years; 2. Presenting with a Dupuytren’s contracture at MCPJ of thumb of at least 20° caused by a palpable cord, or any adduction contracture of the thumb with palpable cords in first web space; 3. In good health, based upon the results of a medical history and physical examination; 4. Female patients of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (i.e. no menses for at least 1 year). A pregnancy test will be performed prior to enrolment in the study in fertile women; 5. Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Nursing or pregnant, or planning to become pregnant during the treatment phase; 2. On an investigational drug within 30 days prior to the first dose of CCH; 3. Received a treatment on the selected joint, within 90 days of enrolment in the study, for Dupuytren’s contracture including needle aponeurotomy or any surgical procedure; 4. Patients with a known systemic hypersensitivity to collagenase or any of the other product excipients; 5. On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150mg daily) within 7 days before the first injection; 6. Has any clinically significant medical history or condition(s), including conditions that affect the hands that would, in the opinion of the investigator, substantially increase the risk associated with the subject’s participation in the protocol or compromise the scientific objectives of the study; 7. Has a chronic muscular, neurological or neuromuscular disorder that affects the hands; 8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and in the judgement of the investigator, would make the subject inappropriate for entry into this study; 9. Has jewellery on the hand to be treated that cannot be removed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in extension deficit to 0-5 degrees 30 days after last injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Goniometry and pollexography will be used to measure baseline and 1, 7, 30 and 90 days and 6 months after last injection for mean change in range of motion from baseline - degrees; 2. Change in “Patient and physician global assessment of treatment satisfaction” from baseline and 7, 30 and 90 days and 6 months after injection, whereby investigator and patient will complete a brief set of questions; 3. Change in outcome of PRWHE DLV (Patient rated wrist/hand evaluation Dutch language version (37)) from baseline and 7, 30 and 90 days and 6 months after injection whereby the patient will fill in the questionnaire; 4. Photographs will be taken of the diseased hand, during screening and at 30 and 90 days and 6 months. | — |
Contacts
Public ContactM. Dreise
Hanzeplein 1
Outcome results
None listed