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NCT01509599 · ClinicalTrials.gov registry record · Phase 1
Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation
A Phase 1 study of Venous Insufficiency and Venous Disease, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 1
- Development phase
- 197
- Enrollment target
- 2
- Study locations
NCT01509599: Completed Phase 1 study of Venous Insufficiency and Venous Disease, sponsored by Medical University of South Carolina.
NCT01509599 is a Phase 1 study of Venous Insufficiency and Venous Disease that has completed, run by Medical University of South Carolina. The registered enrollment target is 197 participants, above the 130-participant average among 9 other Venous Insufficiency trials with a reported enrollment target (52% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01509599, a Phase 1 study of Venous Insufficiency and Venous Disease, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 197 participants
- Enrollment target
- 2
- Study locations
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 |
What the finished NCT01509599 record still lists
NCT01509599 is an interventional study that assigns participants to a tested intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap, above the 130-participant average among 9 other Venous Insufficiency trials with a reported enrollment target (52% higher).
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.
NCT01509599 reports a single indexed study location in South Carolina.
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.
What interventions are being tested in trial NCT01509599?
The interventions under investigation include: Cryotherapy: Cooling gel wrap (PROCEDURE), Usual care (PROCEDURE).
Who is sponsoring clinical trial NCT01509599?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01509599's enrollment target sits among peer trials
197 3rd of 9 higher than 7 of 9 other Venous Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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