Trial · NCT02725528
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
NCT02725528, Phase 3, Completed, McMaster University; results first posted 2023-07-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's. Trials, record NCT02725528. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02725528
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
- NCT number
- NCT02725528
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- McMaster University
- Conditions
- Dupuytren's Disease
- Interventions
- collagenase injection, limited palmar fasciectomy
- First posted
- 2016-04-01
- Last updated
- 2023-07-18
- Results first posted
- 2023-07-18
- Limitations and caveats
Limitations include small sample size, poor recruitment (due health insurance coverage, treatment preference, and the discontinuation of Xiaflex® in Canada), and poor response rate and outcome data collection due to onset and restriction associated with COVID-19 pandemic.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ) | 1 year | Michigan Hand Outcomes Questionnaire (MHQ). Converted to a score rated 0-100 (where higher scores represent better function). |
| Secondary | HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health | 1 year | Health Utility Index Mark 3 (HUI3) of Health. The HUI3 is a generic multi-attribute health-status classification instrument composed of eight attributes or dimensions: vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain with five or six levels per attribute. Dimensions are combined to produce one health utility score. The HUI3 produces health utilities anchored at 0 (minimum) for equal to being dead and 1 (maximum) for perfect health. |
| Secondary | HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM) | 1 year | Unité Rhumatologique des Affections de la Main (URAM). The URAM is a disease-specific HRQL measure developed for Dupuytren's Disease (DD) and is composed of a 9-item patient-reported questionnaire. Each item is scored between 0 and 5 depending on the difficulty in performing that particular function with total scores for DD-associated disability ranging from 0 (best) to 45 (worst). High scores suggest high levels of disability and disturbance. The URAM scale is a 1-domain outcome measure postulated to be related to disability associated with DD. |
| Secondary | HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS) | 1 year | The SDSS is disease-specific scoring system developed for Dupuytren's Disease (DD) with 5 domains, each relevant to DD and scored on a five-point scale (no problem, mild inconvenience, modest inconvenience, definitely troublesome, severe problem). The minimum score is 0 and maximum score is 20 with higher scores suggesting higher levels of disability. |
| Secondary | Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3) | 1 year | QALY was calculated by multiplying the difference between quality of life, as measured by the HUI-3 score before and after the intervention by the remaining years of life of the average patient (i.e., life expectancy - patient's age). Life expectancy was set at 79 years for males, and 84 years for females. Higher QALYs represent improved (better) patient outcomes. |
| Secondary | Recurrence Rates | 1-4 years | Reccurence was measured as whether or not participants received a repeat diagnosis of Dupuytren's disease with loss of finger extension at the site of prior intervention and underwent palmar fasciectomy (following the collagenase injection or as a revision operation) after initial study treatment. The time horizon for recurrence was between 1-4 years post initial study treatment. Outcome was dichotomous (i.e., recurrence; yes or no). |
| Secondary | Loss of Extension MCP | 1 year | Passive range of motion degree of extension was measured using a goniometer. Difference in degree, as measured by a goniometer, between the participant's resting maximum extension of the metacarpal-phalangeal joint, relative to a metacarpal-phalangeal joint at full extension (i.e., 0 degrees) |
| Secondary | Loss of Extension PIP | 1 year | Passive range of motion degree of extension was measured using a goniometer. Difference in degree, as measured by a goniometer, between the participant's resting maximum extension of the proximal inter-phalangeal joint, relative to a proximal inter-phalangeal joint at full extension (i.e., 0 degrees) |
| Secondary | Loss of Extension DIP | 1 year | Passive range of motion degree of extension was measured using a goniometer. Difference in degree, as measured by a goniometer, between the participant's resting maximum extension of the distal inter-phalangeal joint, relative to a distal inter-phalangeal joint at full extension (i.e., 0 degrees) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ) | 1 year | units on a scale | MEAN | |
| SECONDARY | HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health | 1 year | Missing data addressed by using available case analysis. Difference from flow chart due to participant's loss to follow up. Number of participant's in limited palmar fasciectomy group includes 1 additional participant who completed this outcome, but did not complete the primary outcome as indicated in the participant flow chart. | units on a scale | MEAN |
| SECONDARY | HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM) | 1 year | Missing data addressed by using available case analysis. Difference from flow chart due to incomplete data collection for this outcome (i.e. loss to follow up). | units on a scale | MEAN |
| SECONDARY | HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS) | 1 year | Missing data addressed by using available case analysis. Difference from flow chart due to incomplete data collection for this outcome (i.e. loss to follow up). Number of participant's in limited palmar fasciectomy group includes 1 additional participant who completed this outcome, but did not complete the primary outcome as indicated in the participant flow chart. | units on a scale | MEAN |
| SECONDARY | Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3) | 1 year | Missing data addressed by using available case analysis. Difference from flow chart due to incomplete data collection for this outcome (i.e. loss to follow up). Number of participant's in limited palmar fasciectomy group includes 1 additional participant who completed this outcome, but did not complete the primary outcome as indicated in the participant flow chart. | quality-adjusted life years | MEAN |
| SECONDARY | Recurrence Rates | 1-4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Loss of Extension MCP | 1 year | Degrees | MEAN | |
| SECONDARY | Loss of Extension PIP | 1 year | Missing data addressed by using available case analysis. Difference from flow chart due to incomplete data collection for this outcome (i.e. loss to follow up). | Degrees | MEAN |
| SECONDARY | Loss of Extension DIP | 1 year | Missing data addressed by using available case analysis. Difference from flow chart due to incomplete data collection for this outcome (i.e. loss to follow up). | Degrees | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ) | Collagenase Injection | 78.1 | Standard Deviation 14.9 | units on a scale | |
| Health-related Quality of Life (HRQL) Using the Michigan Hand Outcomes Questionnaire (MHQ) | Limited Palmar Fasciectomy | 68.3 | Standard Deviation 15.7 | units on a scale | |
| HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health | Collagenase Injection | 0.8 | Standard Deviation 0.79 | units on a scale | |
| HRQL Measured With the Health Utility Index Mark 3 (HUI3) of Health | Limited Palmar Fasciectomy | 0.79 | Standard Deviation 0.14 | units on a scale | |
| HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM) | Collagenase Injection | 4.6 | Standard Deviation 9.2 | units on a scale | |
| HRQL Measured With the Unité Rhumatologique Des Affections de la Main (URAM) | Limited Palmar Fasciectomy | 5.2 | Standard Deviation 7.6 | units on a scale | |
| HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS) | Collagenase Injection | 6.5 | Standard Deviation 3.2 | units on a scale | |
| HRQL Measured With the Southampton Dupuytren's Scoring Scheme (SDSS) | Limited Palmar Fasciectomy | 7.2 | Standard Deviation 3.7 | units on a scale | |
| Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3) | Collagenase Injection | 0.83 | Standard Deviation 1.7 | quality-adjusted life years | |
| Quality Adjusted Life Years (QALY) Measured With the Health Utility Index Mark 3 (HUI3) | Limited Palmar Fasciectomy | 0.93 | Standard Deviation 2.8 | quality-adjusted life years |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Collagenase Injection | 8 | |
| Overall Study | STARTED | Limited Palmar Fasciectomy | 14 | |
| Overall Study | COMPLETED | Collagenase Injection | 7 | |
| Overall Study | COMPLETED | Limited Palmar Fasciectomy | 9 | |
| Overall Study | NOT COMPLETED | Collagenase Injection | 1 | |
| Overall Study | NOT COMPLETED | Limited Palmar Fasciectomy | 5 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Collagenase Injection | 0 | 8 |
| Total, all-cause mortality | Limited Palmar Fasciectomy | 0 | 13 |
| Total, other adverse events | Collagenase Injection | 0 | 8 |
| Total, other adverse events | Limited Palmar Fasciectomy | 0 | 13 |
| Total, serious adverse events | Collagenase Injection | 0 | 8 |
| Total, serious adverse events | Limited Palmar Fasciectomy | 0 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Collagenase Injection vs Limited Palmar Fasciectomy: Recurrence Rates | Trial comparisons |
| Collagenase Injection vs Limited Palmar Fasciectomy: deaths from any cause | Trial comparisons |
| Collagenase Injection vs Limited Palmar Fasciectomy: serious adverse events | Trial comparisons |
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/NCT02725528
GET https://conductscience.org/api/trials/v1/NCT02725528/registered