Preventing leg ulcers with cryotherapy : A randomized clinical trial

1. Preventing leg ulcers with cryotherapy: A randomized clinical trial Teresa Kelechi, PhD, RN, Martina Mueller, PhD, Jane Zapka, ScD, Dana King, MD, Moby Madisetti, MSc, Carroll Spencer, BSN, RN Medical University of South Carolina SIGNFICIANCE PROCEDURES INNOVATION • Problem: • Chronic venous diseases (CVDs) affect 7 million individuals in the U.S. • 2.5 million with CVDs develop leg ulcers • Microcirculation abnormalities (tissue blood flow) of the skin may be associated with leg ulcers • Cooling the skin with a cryotherapy gel wrap may improve skin microcirculation and prevent leg ulcers • Participants in both groups: • wear compression wraps (JuxtaLite) during waking hours • measure Tsk daily before and after the 30 • minute intervention and 12 hours later with an infrared thermometer • Protocol for using gel or placebo wraps consists of 30 minutes of: • Daily cooling: month 1 • Twice weekly cooling: months 2 - 3 • Once weekly cooling: months 4 - 6 • PRN cooling: months 7 - 9 • For PRN cooling, participants will measure temperature each morning before getting out of bed and cool the skin if a 4ºF increase over baseline is noted for 2 consecutive days. • Analysis: Data will be analyzed using descriptive statistics, paired t-tests, and mixed model analyses. • If study aim is achieved: • gel intervention group will experience 25% fewer new and recurrent ulcers • new clinical practice guidelines that include cryotherapy would result in potential health care savings of $320 million per year • individuals would lose fewer days from work, use less pain medication and experience improved quality of life • the inexpensive non-pharmacologic cooling gel wrap would be widely available for consumer purchase • Actively recruiting: • Spartanburg Regional Medical Center, Spartanburg, SC under the direction of Dr. N. Ulmer, MD • AiyanDiabetes Centers in Evans, Royston, Athens and Augusta, GA under the direction of Dr. S. Jayabalan, PhD, MBA • Seacoast Podiatry Center, Loris, SC under the direction of R. Holmes, FNP, CWOCN, RN • Acknowledgement: This research was funded by the National Institutes of Health, National Institute of Nursing Research R01NR012237-02 • Contact information: kelechtj@musc.edu • 843-792-4602 HYPOTHESIS Purpose: This 9-month clinical trial is underway to study 240 individuals with lower leg skin damage and a history of venous leg ulcers. The aim is to test the hypothesisthat: Acryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression wraps) intervention compared to a low compression non-cryotherapyplacebo wrap (NW) plus UC will: tissue blood flow (microcirculation) and skin temperature (Tsk) the incidence of venous leg pain and quality of life STUDY SITES