DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Clinical Effectiveness of Intrasocket Cooling on Incidence and Severity of Dermatological Conditions in Lower Limb Amputees

Principal Investigator: HIRSCHMAN, GORDON
Institution Receiving Award: VIVONICS, INC.
Program: OPORP
Proposal Number: OP190032
Award Number: W81XWH-20-1-0783
Funding Mechanism: Clinical Trial Award - Funding Level 2
Partnering Awards:
Award Amount: $2,091,529.00
Period of Performance: 9/15/2020 - 9/14/2024


PUBLIC ABSTRACT

With the continued improvements in body armor, and the disturbing increase in explosive offensives in modern combat, more of our wounded Soldiers are surviving their injuries, marking a considerable increase in the military amputee population. Limb loss affects approximately 2.0 million people in the United States, a vast majority of these (86%) being lower limb amputations. A significant portion of both civilians and Soldiers who undergo amputation are now being fitted with state-of-the-art prosthetic devices. Due to the improved functionality of these prostheses, some of these Soldiers are opting to return to active duty after an intensive rehabilitation process (8.8%). Improvements in the prosthetic limb function have outpaced improvements to the fit and comfort of the devices, and so concerns remain with respect to interfacing with the residual limb and the resulting physical demands on the amputee. The residual limb is typically covered by non-breathable and non-thermally conductive materials that can create a warm, moist environment. The trapped heat and perspiration may lead to potential skin issues of the residual limb that have been well documented for decades. These issues include folliculitis, friction blisters, and bacterial growth. In attempts to mitigate the effects that heat and perspiration have on skin health, comfort, and quality of life, various entities across a broad swath of disease states have conducted research around means to manage the temperature of enclosed skin, as is the case in a prosthetic socket. However, there has yet to be validated evidence that thermal management has an effect on the health of dermal tissue and/or resultant quality of life. Therefore, a 4-year clinical trial evaluating the effect of residual limb cooling, on dermatological condition incidence rates and quality of life in Veteran and civilian subjects (N=44) is proposed. With this study, the assembled team seeks to remedy this void in understanding and move the field forward from research into effective prophylactic/therapeutic solutions that promote the health and comfort required to lead an active life.