A Phase 3 interventional study of Triamcinolone Acetonide in Dupuytren's Contracture, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-13.
Sponsored by Sunnybrook Health Sciences Centre · Phase 3, Interventional, and Treatment
Background:
Dupuytren's contracture is a common hand problem that causes certain fingers to bend towards the palm. Patients with this condition cannot perform daily activities and many are unable to work. It is usually treated by an operation to straighten the fingers followed by therapy if the angle that the fingers are bent at is large enough. However, no treatment has been able to completely prevent the angle from persisting.
Objective:
This study is designed to examine whether or not the use of a drug in combination with surgery will improve the angle at which the fingers are bent more than surgery alone.
Hypothesis:
Subjects who receive triamcinolone acetonide will have straighter fingers compared with subjects who only have the operation and no triamcinolone acetonide at both 3 months and 6 months after the operation.
Methods:
Eligible patients interested in having the operation to treat Dupuytren's contracture will be asked if they would like to join the study. Subjects will be randomly placed into one of two groups: the steroid injection group or the control group. Subjects will have a pre-operative visit, the surgery, and follow-ups at 6 weeks, 3 months and 6 months. All subjects will have the operation, but only those in the steroid injection group will receive an injection of the drug. During the 6 week and 3 month follow-ups, subjects in the steroid injection group may receive another injection if their fingers are still bent. Angles are measured at the pre-operative visit and at 3 and 6 months. The change in angle from before to after and any differences in the groups, in time points and interactions between the two will be analyzed.
76 studies on the registry are indexed under Dupuytren Contracture; 16 are open to participants now.
This study's enrollment of 51 is below the median of 72 across 55 interventional studies indexed under Dupuytren Contracture.
Browse Dupuytren Contracture studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
Drug: Triamcinolone Acetonide
* Triamcinolone acetonide will be administered into the cord following surgery with a tuberculin syringe and a 25-gauge needle. * Doses will range from 60-120 mg depending on extent of the disease. * Patients will receive injections at 6 weeks and 3 months for persisting nodules or cords. * PI will determine the dosages. Estimates will be made based on the following: Size of nodule/cord: 1-2 cm2, dosage 20-40 mg Size of nodule/cord: 2-6 cm2, dosage 40-80 mg Size of nodule/cord: 6-10 cm2, dosage 80-100 mg Size of nodule/cord: \>10 cm2, dosage 100-120 mg
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).
Time frame: 6 months
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre