Trial · NCT01265420
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
NCT01265420, Phase 4, Completed, Indiana Hand to Shoulder Center; results first posted 2015-04-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb. Trials, record NCT01265420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01265420
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
- NCT number
- NCT01265420
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 7 participants, actual
- Lead sponsor
- Indiana Hand to Shoulder Center
- Conditions
- Dupuytren's Contracture
- Interventions
- Injectable clostridial collagenase
- First posted
- 2010-12-23
- Last updated
- 2015-04-30
- Results first posted
- 2015-04-09
- Limitations and caveats
- 1 patient was seen at Day 10, but not at day 30. At Day 10, patient met the primary endpoint
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | 30 days after last injection |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | 30 days after last injection | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | Injectable Clostridial Collagenase | >50% reduction in contracture | 5 | participants | |
| Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture) | Injectable Clostridial Collagenase | <50% reduction in contracture | 1 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Injectable Clostridial Collagenase | 7 | |
| Overall Study | COMPLETED | Injectable Clostridial Collagenase | 6 | |
| Overall Study | NOT COMPLETED | Injectable Clostridial Collagenase | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | Ecchymosis | Skin and subcutaneous tissue disorders | Injectable Clostridial Collagenase | 7 | 7 | |
| other | Edema | Skin and subcutaneous tissue disorders | Injectable Clostridial Collagenase | 7 | 7 | |
| other | Pruritis | Skin and subcutaneous tissue disorders | Injectable Clostridial Collagenase | 1 | 7 | |
| other | Paresthesia | Nervous system disorders | Injectable Clostridial Collagenase | 1 | 7 | |
| other | nausea | Gastrointestinal disorders | Injectable Clostridial Collagenase | 1 | 7 | |
| other | Skin Tear | Skin and subcutaneous tissue disorders | Injectable Clostridial Collagenase | 1 | 7 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Injectable Clostridial Collagenase | ||
| Total, other adverse events | Injectable Clostridial Collagenase | 7 | 7 |
| Total, serious adverse events | Injectable Clostridial Collagenase | 0 | 7 |
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/NCT01265420
GET https://conductscience.org/api/trials/v1/NCT01265420/registered