CClinicalTrials.gg
Sign In
TerminatedNCT01226121Updated Jun 16, 2014Results posted

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

A Phase 4 interventional study of Clostridial collagenase injectable in Dupuytren's Disease, sponsored by Indiana Hand to Shoulder Center. Terminated at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-16.

Sponsored by Indiana Hand to Shoulder Center · Phase 4, Interventional, and Treatment

Why this study was terminated
difficulty enrolling additional patients
Phase
Phase 4
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,

02

Conditions studied

  • Dupuytren's Disease

Keywords

  • dupuytren
  • dupuytren's
03

In context

Dupuytren Contracture

76 studies on the registry are indexed under Dupuytren Contracture; 16 are open to participants now.

This study's enrollment of 37 is below the median of 72 across 55 interventional studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

Indiana Hand to Shoulder Center is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adult subjects (> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture

Exclusion criteria

Exclusion Criteria:

  • Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
  • Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
  • Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
  • Any subject with known allergy to Xiaflex (Clostridial collagenase).
  • Any subject who cannot conform to the study visit schedule
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Day 1 manipulation

    Finger manipulation one day following Clostridial collagenase injectable

    Biological: Clostridial collagenase injectable

  • Active comparator
    Day 2 manipulation

    Finger manipulation two days following Clostridial collagenase injectable

    Biological: Clostridial collagenase injectable

  • Active comparator
    Day 4 manipulation

    Finger manipulation four days following Clostridial collagenase injectable

    Biological: Clostridial collagenase injectable

Interventions

  • BiologicalClostridial collagenase injectable

    Finger manipulation performed 1, 2, or 4 days following collagenase injection

06

What researchers measure

Primary outcomes

  1. Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)

    Time frame: 30 days after injection

Secondary outcomes

  1. Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)

    Time frame: 90 days

07

Results

Posted Jun 16, 2014
Limitations and caveats
Study was terminated early due to slow enrollment

Participant flow

Participant flow — Overall Study
MilestoneDay 1 ManipulationDay 2 ManipulationDay 4 Manipulation
Started131113
30 day evaluation121113
Completed111112
Not completed201
Withdrew: Lost to follow-up201

Outcome measures

PrimaryPercentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
Time frame:
30 days after injection
Reported as:
Number · percentage of participants
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
percentage of participantsDay 1 ManipulationDay 2 ManipulationDay 4 Manipulation
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)929185
SecondaryPercentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
Time frame:
90 days
Reported as:
Number · percentage of patients
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)
percentage of patientsDay 1 ManipulationDay 2 ManipulationDay 4 Manipulation
Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)918283

Adverse events

Collected over data collected for 90 day period patients were followed following injection. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Day 1 Manipulation—0/13 (0%)13/13 (100%)
Day 2 Manipulation—0/11 (0%)11/11 (100%)
Day 4 Manipulation—0/13 (0%)13/13 (100%)
Most frequent other events
Most frequent other events
EventDay 1 ManipulationDay 2 ManipulationDay 4 Manipulation
EdemaSkin and subcutaneous tissue disorders13/139/1110/13
BruisingSkin and subcutaneous tissue disorders9/138/119/13
PainNervous system disorders1/135/115/13
pruritisSkin and subcutaneous tissue disorders1/133/111/13
BlisterSkin and subcutaneous tissue disorders3/130/112/13
LymphadenopathyBlood and lymphatic system disorders3/132/110/13
Skin tearSkin and subcutaneous tissue disorders2/132/110/13

Baseline characteristics

Age, Continuous
Age, Continuous(years)Day 1 ManipulationDay 2 ManipulationDay 4 ManipulationTotal
Mean63.9 ± 10.367 ± 6.465.5 ± 10.265.44 ± 9.02
Sex: Female, Male
Sex: Female, Male(Participants)Day 1 ManipulationDay 2 ManipulationDay 4 ManipulationTotal
Female0213
Male1391234
Region of Enrollment
Region of Enrollment(participants)Day 1 ManipulationDay 2 ManipulationDay 4 ManipulationTotal
United States13111337
08

Study locations

2 sites
  • Indiana Hand to Shoulder Center
    Indianaplis, Indiana 46260, United States
  • Stony Brook University
    Stony Brook, New York 11794, United States
09

References and documents

Publications

  • Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866. PubMed 19726771 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01226121
Lead sponsor
Indiana Hand to Shoulder Center
Collaborators
Stony Brook University
Responsible party
F. Thomas D. Kaplan, MD (MD, Indiana Hand to Shoulder Center) — Principal investigator
First posted
Oct 21, 2010
Start date
Dec 2010
Primary completion
Dec 2012
Completion
Dec 2012
Results posted
Jun 16, 2014
Last update
Jun 16, 2014

Study contacts

F. Thomas D. Kaplan, MD
principal investigator · Indiana Hand to Shoulder Center
Lawrence C Hurst, MD
principal investigator · Stony Brook University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dupuytren Contracture→

Other studies from this sponsor

Indiana Hand to Shoulder Center

Start the discussion