Trial · NCT01226121
Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
NCT01226121, Phase 4, Terminated, Indiana Hand to Shoulder Center; results first posted 2014-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture. Trials, record NCT01226121. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01226121
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
- NCT number
- NCT01226121
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 37 participants, actual
- Lead sponsor
- Indiana Hand to Shoulder Center
- Conditions
- Dupuytren's Disease
- Interventions
- Clostridial collagenase injectable
- First posted
- 2010-10-21
- Last updated
- 2014-06-16
- Results first posted
- 2014-06-16
- Limitations and caveats
- Study was terminated early due to slow enrollment
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | 30 days after injection | |
| Secondary | Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | 90 days |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | 30 days after injection | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | 90 days | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | Day 1 Manipulation | 92 | percentage of participants | ||
| Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | Day 2 Manipulation | 91 | percentage of participants | ||
| Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture) | Day 4 Manipulation | 85 | percentage of participants | ||
| Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | Day 1 Manipulation | 91 | percentage of patients | ||
| Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | Day 2 Manipulation | 82 | percentage of patients | ||
| Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture) | Day 4 Manipulation | 83 | percentage of patients |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Day 1 Manipulation | 13 | |
| Overall Study | STARTED | Day 2 Manipulation | 11 | |
| Overall Study | STARTED | Day 4 Manipulation | 13 | |
| Overall Study | 30 Day Evaluation | Day 1 Manipulation | 12 | |
| Overall Study | 30 Day Evaluation | Day 2 Manipulation | 11 | |
| Overall Study | 30 Day Evaluation | Day 4 Manipulation | 13 | |
| Overall Study | COMPLETED | Day 1 Manipulation | 11 | |
| Overall Study | COMPLETED | Day 2 Manipulation | 11 | |
| Overall Study | COMPLETED | Day 4 Manipulation | 12 | |
| Overall Study | NOT COMPLETED | Day 1 Manipulation | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Edema | Skin and subcutaneous tissue disorders | Day 1 Manipulation | 13 | 13 | |
| other | Edema | Skin and subcutaneous tissue disorders | Day 2 Manipulation | 9 | 11 | |
| other | Edema | Skin and subcutaneous tissue disorders | Day 4 Manipulation | 10 | 13 | |
| other | Bruising | Skin and subcutaneous tissue disorders | Day 1 Manipulation | 9 | 13 | |
| other | Bruising | Skin and subcutaneous tissue disorders | Day 2 Manipulation | 8 | 11 | |
| other | Bruising | Skin and subcutaneous tissue disorders | Day 4 Manipulation | 9 | 13 | |
| other | Pain | Nervous system disorders | Day 1 Manipulation | 1 | 13 | |
| other | Pain | Nervous system disorders | Day 2 Manipulation | 5 | 11 | |
| other | Pain | Nervous system disorders | Day 4 Manipulation | 5 | 13 | |
| other | Blister | Skin and subcutaneous tissue disorders | Day 1 Manipulation | 3 | 13 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Day 1 Manipulation | ||
| Total, all-cause mortality | Day 2 Manipulation | ||
| Total, all-cause mortality | Day 4 Manipulation | ||
| Total, other adverse events | Day 1 Manipulation | 13 | 13 |
| Total, other adverse events | Day 2 Manipulation | 11 | 11 |
| Total, other adverse events | Day 4 Manipulation | 13 | 13 |
| Total, serious adverse events | Day 1 Manipulation | 0 | 13 |
| Total, serious adverse events | Day 2 Manipulation | 0 | 11 |
| Total, serious adverse events | Day 4 Manipulation | 0 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 19726771 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01226121
GET https://conductscience.org/api/trials/v1/NCT01226121/events?page=2