Trial · NCT02915835
Riociguat in Scleroderma Associated Digital Ulcers
NCT02915835, Phase 2, Completed, Dinesh Khanna, MD, MS; results first posted 2019-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Riociguat in Scleroderma Associated Digital Ulcers. Trials, record NCT02915835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02915835
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Riociguat in Scleroderma Associated Digital Ulcers
- NCT number
- NCT02915835
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Dinesh Khanna, MD, MS
- Conditions
- Scleroderma, Digital Ulcers
- Interventions
- Riociguat, Placebo
- First posted
- 2016-09-27
- Last updated
- 2019-09-24
- Results first posted
- 2019-09-24
Source ClinicalTrials.gov
Registered outcomes60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to End of Double-blind Treatment (Week 16) in Digital Ulcer Net Burden | Baseline to Week 16 | Digital ulcer net burden is defined as the total number of "active" and indeterminate digital ulcers at an assessment. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. A healed ulcer has complete re-epithelialization. |
| Secondary | Proportion of Participants With Healing of Their Cardinal DU by Week 16 | Week 16 | The proportion of participant whose active digital ulcer that was identified and designated by the investigator as the cardinal ulcer at Baseline is healed by week 16. The cardinal ulcer will be selected by the investigator based on the clinical judgment that it was amenable to and evaluable for healing. If there are several active digital ulcers, the cardinal ulcer could be either the largest or the most painful ulcer, or the ulcer that disturbed the patient the most. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. |
| Secondary | Proportion of Participants With Healing of All DUs at Baseline by Week 16 | Week 16 | The proportion of participants whose baseline DUs are considered healed (classified as 'healed' and not 'active' or 'indeterminate') by week 16. All baseline ulcers must be healed for the participant to be classified as having all baseline ulcers healed. Note that this end point does not consider whether a participant develops new DUs during the course of the study. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. A healed ulcer has complete re-epithelialization. |
| Secondary | Proportion of Participants With no DUs at Week 16 | Week 16 | The proportion of participants with no digital ulcers at week 16. This end point does not consider the number of ulcers at baseline or during the course of the study; only the absence of 'active' and 'indeterminate' DUs at week 16. Active ulcers are defined as having a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. A healed ulcer has complete re-epithelialization. |
| Secondary | Proportion of Participants With New Active and Indeterminate DU(s) Over the Course of the Double-blind Period | Baseline to Week 16 | The proportion of participants with new (i.e., not present at baseline) active and indeterminant DUs from baseline to Week 16. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. |
| Secondary | Proportion of Participants Who Develop Pressure Ulcers at Distal Interphalangeal (DIP) Location Over the Course of the Double-blind Period. | Baseline to Week 16 | The proportion of participants who develop a DIP pressure ulcer at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. |
| Secondary | Proportion of Participants Who Develop Pressure Ulcers at Proximal Interphalangeal (PIP) Location Over the Course of the Double-blind Period. | Baseline to Week 16 | The proportion of participants who develop a PIP pressure ulcer at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. |
| Secondary | Proportion of Participants Who Develop Pressure Ulcers at Metacarpophalangeal (MCPs) Location Over the Course of the Double-blind Period. | Baseline to Week 16 | The proportion of participants who develop a MCP pressure ulcer at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. |
| Secondary | Proportion of Participants Who Develop Pressure Ulcers at the Elbows Over the Course of the Double-blind Period. | Baseline to Week 16 | The proportion of participants who develop a pressure ulcer at at the elbows at baseline to Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. |
| Secondary | Proportion of Participants With Healing of All Pressure Ulcers at the Distal Interphalangeal (DIP) Over the Course of the Double-blind Period. | Baseline to Week 16 | The proportion of participants whose DIP pressure ulcers during the double-blind period were healed at Week 16. Pressure ulcer is defined as an active or indeterminate ulcer. An active ulcer is defined as a denuded area with defined border and loss of epithelialization, loss of epidermis and dermis. An indeterminate ulcer is defined as denudation that could not be visualized and no other clinical features of activity. |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 registered outcomesOutcomes60
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to End of Double-blind Treatment (Week 16) in Digital Ulcer Net Burden | Baseline to Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | ulcers | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants With Healing of Their Cardinal DU by Week 16 | Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Healing of All DUs at Baseline by Week 16 | Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With no DUs at Week 16 | Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With New Active and Indeterminate DU(s) Over the Course of the Double-blind Period | Baseline to Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants Who Develop Pressure Ulcers at Distal Interphalangeal (DIP) Location Over the Course of the Double-blind Period. | Baseline to Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants Who Develop Pressure Ulcers at Proximal Interphalangeal (PIP) Location Over the Course of the Double-blind Period. | Baseline to Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants Who Develop Pressure Ulcers at Metacarpophalangeal (MCPs) Location Over the Course of the Double-blind Period. | Baseline to Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants Who Develop Pressure Ulcers at the Elbows Over the Course of the Double-blind Period. | Baseline to Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Participants With Healing of All Pressure Ulcers at the Distal Interphalangeal (DIP) Over the Course of the Double-blind Period. | Baseline to Week 16 | Modified Intent to Treat Population is defined as all participants randomized, receiving at least one dose of treatment, and having at least one post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to End of Double-blind Treatment (Week 16) in Digital Ulcer Net Burden | Riociguat | -1.22 | Standard Error 0.458 | ulcers | |
| Change From Baseline to End of Double-blind Treatment (Week 16) in Digital Ulcer Net Burden | Placebo | -0.98 | Standard Error 0.425 | ulcers | |
| Proportion of Participants With Healing of Their Cardinal DU by Week 16 | Riociguat | 4 | Participants | ||
| Proportion of Participants With Healing of Their Cardinal DU by Week 16 | Placebo | 6 | Participants | ||
| Proportion of Participants With Healing of All DUs at Baseline by Week 16 | Riociguat | 3 | Participants | ||
| Proportion of Participants With Healing of All DUs at Baseline by Week 16 | Placebo | 3 | Participants | ||
| Proportion of Participants With no DUs at Week 16 | Riociguat | 2 | Participants | ||
| Proportion of Participants With no DUs at Week 16 | Placebo | 2 | Participants | ||
| Proportion of Participants With New Active and Indeterminate DU(s) Over the Course of the Double-blind Period | Riociguat | 3 | Participants | ||
| Proportion of Participants With New Active and Indeterminate DU(s) Over the Course of the Double-blind Period | Placebo | 4 | Participants |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Riociguat | 9 | |
| Overall Study | STARTED | Placebo | 8 | |
| Overall Study | COMPLETED | Riociguat | 8 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Riociguat | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events52
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 | Anemia | Blood and lymphatic system disorders | Riociguat | 1 | 9 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 0 | 8 | 0 |
| other | Splenic infarct | Blood and lymphatic system disorders | Riociguat | 1 | 9 | 1 |
| other | Splenic infarct | Blood and lymphatic system disorders | Placebo | 0 | 8 | 0 |
| other | Heart Murmur | Cardiac disorders | Riociguat | 1 | 9 | 1 |
| other | Heart Murmur | Cardiac disorders | Placebo | 0 | 8 | 0 |
| other | Left bundle bramch block on EKG | Cardiac disorders | Riociguat | 0 | 9 | 0 |
| other | Left bundle bramch block on EKG | Cardiac disorders | Placebo | 1 | 8 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Riociguat | 0 | 9 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 1 | 8 | 1 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Riociguat | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 8 |
| Total, other adverse events | Riociguat | 9 | 9 |
| Total, other adverse events | Placebo | 8 | 8 |
| Total, serious adverse events | Riociguat | 3 | 9 |
| Total, serious adverse events | Placebo | 1 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31481106 | DERIVED |
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 comparisons16
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Riociguat vs Placebo: Proportion of Participants Who Develop Pressure Ulcers at Proximal Interphalangeal (PIP) Location Over the Course of the Double-blind Period. | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants With New Active and Indeterminate DU(s) Over the Course of the Double-blind Period | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants With Healing of Their Cardinal DU by Week 16 | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants Who Experience Digital Ischemia Requiring Intravenous Prostacyclin or Digital Gangrene or Amputation During the Trial. | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants Who Develop Pressure Ulcers at Distal Interphalangeal (DIP) Location Over the Course of the Double-blind Period. | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants With Healing of All Pressure Ulcers at the Elbows Over the Course of the Double-blind Period. | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants With Healing of All DUs at Baseline by Week 16 | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants With Healing of All Pressure Ulcers at the Proximal Interphalangeal (PIP) Over the Course of the Double-blind Period. | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants With no DUs at Week 16 | Trial comparisons |
| Riociguat vs Placebo: Proportion of Participants With Healing of All Pressure Ulcers at the Metacarpophalangeal (MCPs) Over the Course of the Double-blind Period. | Trial comparisons |
1 to 10 of 16
See all 16 trial comparisonsTests0
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02915835
GET https://conductscience.org/api/trials/v1/NCT02915835/registered?page=2