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Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation
NCT01509599 · View on ClinicalTrials.gov ↗
Study Summary
Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy "sham" wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.
Conditions Studied
Interventions
- PROCEDURE Cryotherapy: Cooling gel wrap
- PROCEDURE Usual care
Study Locations (2)
South Carolina
- Medical University of South Carolina — Charleston
- Spartanburg Regional Medical Center — Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01509599
The ClinicalTrials.gov registry entry for NCT01509599 describes a study currently listed as completed. It is categorized as Phase 1, 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 197 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Venous Insufficiency appearing as the primary indexed condition, and to 2 interventions — of which Cryotherapy: Cooling gel wrap 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: NCT01509599 reports 2 study locations spanning 1 distinct geographic area — top geographies include South Carolina. 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 NCT01509599 about?
NCT01509599 is a clinical study titled "Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation". Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, b...
What is the current status of trial NCT01509599?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 197 participants. The study started on 2011-08. Estimated completion is 2015-12.
What conditions does trial NCT01509599 study?
This clinical trial studies the following conditions: Venous Insufficiency, Venous Disease, Venous Ulcers, Venous Vascular Diseases and Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01509599?
The interventions under investigation include: Cryotherapy: Cooling gel wrap (PROCEDURE), Usual care (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01509599?
This trial is sponsored by Medical University of South Carolina, which has 643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01509599 being conducted?
This trial has 2 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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