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COMPLETED Phase 2

A Two-Part Study of BOTOX® Therapy for Ischemic Digits

NCT01309802 · View on ClinicalTrials.gov ↗

Study Summary

Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is extremely challenging. Published reports and our previous work support our hypothesis that symptomatic patients experience relief of pain and healing of ulcerations with minimal adverse effects when treated with botulinum toxin type A (Btx-A) injections for Raynaud's phenomenon. The proposed study is the first clinical trial and prospective study designed to document whether or not 1) Btx-A injection relieves pain in a patient's hand affected with Raynaud's disease better than a placebo within 28 days of injection, and 2) Btx-A injection relieves pain associated with Raynaud's disease for longer than 28 days, improving patients' quality of life. Through this study we intend to further determine the effect of injected Btx-A on relieving chronic pain and ulcerations to the ischemic hand while characterizing the patients for whom this treatment is most effective.

Conditions Studied

Interventions

  • DRUG onabotulinum toxin type-A

Study Locations (1)

Illinois

  • Southern Illinois University School of Medicine — Springfield

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2011-05
Est. Completion 2016-07-13
Phase Phase 2

Sponsor

Southern Illinois University

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01309802

The ClinicalTrials.gov registry entry for NCT01309802 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southern Illinois University, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Raynaud's Disease appearing as the primary indexed condition, and to 1 intervention — of which onabotulinum toxin type-A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01309802 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01309802 about?

NCT01309802 is a clinical study titled "A Two-Part Study of BOTOX® Therapy for Ischemic Digits". Treating patients with Raynaud's phenomenon who have chronic pain and ulcerations is extremely challenging. Published reports and our previous work support our hypothesis that symptomatic patients experience relief of pain and healing of ulcerations with minimal adverse effects when treated with bot...

What is the current status of trial NCT01309802?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2011-05. Estimated completion is 2016-07-13.

What conditions does trial NCT01309802 study?

This clinical trial studies the following conditions: Raynaud's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01309802?

The interventions under investigation include: onabotulinum toxin type-A (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01309802?

This trial is sponsored by Southern Illinois University, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01309802 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial