Trial · NCT01309802
A Two-Part Study of BOTOX® Therapy for Ischemic Digits
NCT01309802, Phase 2, Completed, Southern Illinois University; results first posted 2017-06-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Two-Part Study of BOTOX® Therapy for Ischemic Digits. Trials, record NCT01309802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01309802
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two-Part Study of BOTOX® Therapy for Ischemic Digits
- NCT number
- NCT01309802
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Southern Illinois University
- Conditions
- Raynaud's Disease
- Interventions
- onabotulinum toxin type-A
- First posted
- 2011-03-07
- Last updated
- 2019-01-08
- Results first posted
- 2017-06-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patient Reported Pain-free Days | baseline to 28 days | Subjective pain scales \[visual analogue scale (VAS) and faces pain assessment\]. Subjects reporting total number of pain free days within the time period of 0-28 days. |
| Secondary | Pain Related Quality of Life | change from baseline to 28 days | SF-12v2® Health Survey - Pain Enhanced |
| Secondary | Hand Function | baseline to 28 days | Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) Outcome Measure |
| Secondary | Patient Satisfaction | baseline to 28 days | The Optum SF-12v2® Health Survey - A Short Patient Reported Survey Measuring Health Using Excellent, Very Good, Good, Fair and Poor Indicators. On a scale from Excellent to Poor, Excellent being the maximum outcome. Good is scored as average. Patient satisfaction assessed as the percentage of participants who responded; Excellent, Very Good and Good on the health survey on average feeling between baseline and 28 days. |
| Secondary | Tissue Perfusion | baseline to 28 days | Doppler perfusion imager and Periscan image analysis software |
| Secondary | EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal | baseline to 28 days | A combined reported score measuring 5 dimensions; mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels; no problems, some problems, extreme problems |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patient Reported Pain-free Days | baseline to 28 days | percentage of pain free days | NUMBER | |
| SECONDARY | Pain Related Quality of Life | change from baseline to 28 days | Data were not collected, | ||
| SECONDARY | Hand Function | baseline to 28 days | Data were not collected | ||
| SECONDARY | Patient Satisfaction | baseline to 28 days | percentage of participants | NUMBER | |
| SECONDARY | Tissue Perfusion | baseline to 28 days | Data were not collected | ||
| SECONDARY | EQ-5D A Standardised Patient Reported Measure of Health Status for Clinical and Economic Appraisal | baseline to 28 days | not were not collected |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patient Reported Pain-free Days | Placebo | 12 | percentage of pain free days | ||
| Percentage of Patient Reported Pain-free Days | Onabotulinum Toxin Type-A | 48 | percentage of pain free days | ||
| Patient Satisfaction | Placebo | 12 | percentage of participants | ||
| Patient Satisfaction | Onabotulinum Toxin Type-A | 48 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 25 | |
| Overall Study | STARTED | Onabotulinum Toxin Type-A | 23 | |
| Overall Study | COMPLETED | Placebo | 13 | |
| Overall Study | COMPLETED | Onabotulinum Toxin Type-A | 14 | |
| Overall Study | NOT COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Onabotulinum Toxin Type-A | 9 |
Source ClinicalTrials.gov
Adverse events34
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 | Pain, Redness, Bleeding | General disorders | Placebo | 14 | 25 | 35 |
| other | Pain, Redness, Bleeding | General disorders | Onabotulinum Toxin Type-A | 14 | 23 | 31 |
| other | Swelling, Tenderness, Bruising | General disorders | Placebo | 12 | 25 | 17 |
| other | Swelling, Tenderness, Bruising | General disorders | Onabotulinum Toxin Type-A | 7 | 23 | 9 |
| other | Temporary Weakness or numbness of muscle | Musculoskeletal and connective tissue disorders | Placebo | 16 | 25 | 32 |
| other | Temporary Weakness or numbness of muscle | Musculoskeletal and connective tissue disorders | Onabotulinum Toxin Type-A | 11 | 23 | 20 |
| other | Dizziness, Drowsiness | General disorders | Placebo | 3 | 25 | 3 |
| other | Dizziness, Drowsiness | General disorders | Onabotulinum Toxin Type-A | 3 | 23 | 4 |
| other | Dry Eyes, Dry Mouth | General disorders | Placebo | 1 | 25 | 2 |
| other | Dry Eyes, Dry Mouth | General disorders | Onabotulinum Toxin Type-A | 0 | 23 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 25 |
| Total, all-cause mortality | Onabotulinum Toxin Type-A | 0 | 23 |
| Total, other adverse events | Placebo | 25 | 25 |
| Total, other adverse events | Onabotulinum Toxin Type-A | 22 | 23 |
| Total, serious adverse events | Placebo | 5 | 25 |
| Total, serious adverse events | Onabotulinum Toxin Type-A | 2 | 23 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Onabotulinum Toxin Type-A vs Placebo: deaths from any cause | Trial comparisons |
| Onabotulinum Toxin Type-A vs Placebo: 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/NCT01309802
GET https://conductscience.org/api/trials/v1/NCT01309802/events?page=2