Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 May;24(2):71-9.
doi: 10.1016/j.jtv.2015.01.006. Epub 2015 Feb 7.

Impact of daily cooling treatment on skin inflammation in patients with chronic venous disease

Teresa J Kelechi  1 , Martina Mueller  2 , Dana E King  3 , Mohan Madisetti  2 , Margie Prentice  2
Affiliations
Randomized Controlled Trial

Impact of daily cooling treatment on skin inflammation in patients with chronic venous disease

Teresa J Kelechi et al. J Tissue Viability. 2015 May.

Abstract

People with chronic venous disease are at high risk for developing venous leg ulcers. Inflammation is posited as a pathological factor for this chronic condition as evidenced by persistently elevated skin temperature. As part of a larger trial to test the effects of a cooling regimen on leg ulcer prevention, the objective of this preliminary study was to evaluate the first 30 days of intense daily cooling. Compared to a placebo control cuff, a gel cuff applied to the most severely affected lower leg skin for 30 min daily showed no statistically significant differences between temperatures taken in the home at baseline compared to those measured at the 1 month follow up visit. There were also no differences in temperatures noted between the two groups, although the temperatures in the treatment group were lower 30 min after treatment, an indication of adherence. There was no discernable decrease or increase in temperature at a given time point during the 30 day treatment period compared to the control group. It may be better to have patients monitor skin temperature on a daily basis and then apply the cuff as necessary, rather than requiring daily cooling based on baseline measurement. This "prn" approach may provide a sufficient cooling milieu to prevent escalation of inflammation and thwart ulcer occurrence or recurrence. Clinical trials registration #NCT01509599.

Keywords: Chronic venous disease; Inflammation; Local cooling; Skin temperature.

PubMed Disclaimer

Conflict of interest statement

Conflict of interest statement: There are no conflicts of interest associated with this study.

Figures

Figure 1
Figure 1. CONSORT flow chart
Figure 2
Figure 2
A. Bland-Altman plot of baseline clinic and patient log temperature agreement. B. Bland-Altman plot of month 1 clinic and patient log temperature agreement.
Figure 2
Figure 2
A. Bland-Altman plot of baseline clinic and patient log temperature agreement. B. Bland-Altman plot of month 1 clinic and patient log temperature agreement.
Figure 3
Figure 3
A. Morning temperature B. Before treatment temperature C. After treatment temperatures
Figure 3
Figure 3
A. Morning temperature B. Before treatment temperature C. After treatment temperatures
Figure 3
Figure 3
A. Morning temperature B. Before treatment temperature C. After treatment temperatures
See this image and copyright information in PMC

References

    1. Neglen P, Eklof B, Kulwicki A, Davies A, Deschamps T, et al. Writing Group IIotPVS. Prevention and treatment of venous ulcers in primary chronic venous insufficiency. J Vasc Surg. 2010;52:15S–20S. - PubMed
    1. Simka M. Cellular and molecular mechanisms of venous leg ulcers development--the “puzzle” theory. Int Angiol. 2010;29:1–19. - PubMed
    1. Smith PC. The causes of skin damage and leg ulceration in chronic venous disease. Int J Low Extrem Wounds. 2006;5:160–8. - PubMed
    1. Mannello F, Raffetto JD. Matrix metalloproteinase activity and glycosaminoglycans in chronic venous disease: the linkage among cell biology, pathology and translational research. Am J Transl Res. 2011;3:149–58. - PMC - PubMed
    1. Raffetto JD. Dermal pathology, cellular biology, and inflammation in chronic venous disease. Thromb Res. 2009;123(Suppl 4):S66–71. - PubMed

Publication types

Associated data