Venous Insufficiency — Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation
Citation(s)
Kelechi TJ, Johnson JJ, Yates S Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003.
Kelechi TJ, Madisetti M, Mueller M, Dooley M, Prentice M Self-monitoring of lower leg skin temperature: accuracy of self-reported data and adherence to a cooling protocol for the prevention of venous leg ulcers. Patient Prefer Adherence. 2015 Dec 15;9:17
Kelechi TJ, Mueller M, Dooley M Sex differences in symptom severity and clusters in patients with stage C4 and stage C5 chronic venous disease. Eur J Cardiovasc Nurs. 2016 Feb 17. pii: 1474515116634526. [Epub ahead of print]
Kelechi TJ, Mueller M, King DE, Madisetti M, Prentice M Impact of daily cooling treatment on skin inflammation in patients with chronic venous disease. J Tissue Viability. 2015 May;24(2):71-9. doi: 10.1016/j.jtv.2015.01.006. Epub 2015 Feb 7.
Preventing Venous Leg Ulcers With Cryotherapy: A Randomized Clinical Trial
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
