DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Posted June 10, 2022

Ryan Myers, Ph.D., Vivonics, Inc.
Glenn Klute, Ph.D., Seattle Institute for Biomedical and Clinical Research

There are nearly two million individuals in the United States living with limb loss, many of whom rely on the use of prosthetic devices.1 A good prosthesis fit requires tight contact between the residual limb, prosthetic liner and socket, which inherently leads to poor ventilation and air circulation to the residual limb and skin. The lack of ventilation in the socket causes the skin temperature to rise and perspiration to accumulate, resulting in discomfort, skin irritation, friction blisters, infection, and even unpleasant odors, all of which have the potential to affect the user’s overall quality of life.2 Residual limb perspiration is not uncommon for prosthesis users; 53% have reported experiencing discomfort associated with heat and perspiration from their prosthesis.3 Even though excessive sweating is commonly experienced by prosthesis users, there are currently no relevant guidelines for use by clinicians. The Orthotics and Prosthetics Outcomes Research Program (OPORP) has recently funded two Clinical Trial Awards focused on addressing residual limb perspiration.

Dr. Ryan Myers
Dr. Ryan Myers

With funding from a Fiscal Year 2019 (FY19) OPORP Clinical Trial Award, Dr. Ryan Myers (Vivonics, Inc.; Bedford, MA) is assessing whether the Intra-socket Cooling Element (ICE) System, co-developed by Vivonics, Inc. and Liberating Technologies, Inc., can statistically and significantly improve the quality of life of lower limb amputees by decreasing the occurrence of skin conditions caused by residual limb heat and perspiration. The ICE system is a module that can be inserted into the socket to remove heat trapped between the user’s skin and the prosthetic socket. The initial design for the ICE system was first supported by the U.S. Army Small Business Innovation Research Program and further developed with funding from the Peer Reviewed Orthopaedic Research Program. The research team received follow-on funding from the Joint Warfighter Medical Research Program to expand upon the cooling design and clinically evaluate its ability to cool the residual limb through a clinical study at the Minneapolis Veteran Affairs Health Care System. The current OPORP funding provides support for the first clinical trial to test the efficacy of active cooling technology on patient outcomes. Dr. Myers, Liberating Technologies, Inc. (site Principal Investigator [PI]: Todd Farrell, PhD), the Minneapolis VA (site PI: Sara Koehler-McNicholas, PhD), and Ability Prosthetics and Orthotics (site PI: Brian Kaluf, CP, FAAOP) plan to recruit lower limb amputees to test the theory that cooling at the prosthetic interface will improve skin health and overall dermatological quality of life. This clinical trial will address a gap in the healthcare needs of prosthesis users and explore the issue of temperature management at the prosthetic interface as it relates to overall prosthetic comfort. The anticipated results from the proposed study have the potential to inform both the research and clinical community in the treatment of lower limb amputation and the usefulness of socket cooling in addressing socket perspiration, one of the most prevalent side effects of prosthesis use.

Dr. Glenn Klute
Dr. Glenn Klute

On the other side of the country, Dr. Glenn Klute (Seattle Institute for Biomedical and Clinical Research; Seattle, WA) is evaluating the benefit of perforating (i.e., making holes in) clinically available liners or use of a liner-liner sock in lower limb amputees to mitigate the adverse effects of residual limb perspiration. Liner-liner socks are currently used in the clinic and worn between the skin and the liner to wick away perspiration from the skin. Perforating liners with small holes is a relatively newer idea in the field, and aims to decrease accumulated perspiration. With the support of a FY20 OPORP Clinical Trial Award, Dr. Klute and his team will measure the stability, suspension, and comfort of these clinically available modified liner options with the goal of identifying guidance to aid clinicians in their prescription. For many individuals, when excess perspiration occurs on their residual limb, they have the choice of removing their prosthesis (oftentimes for several days), drying it and their residual limb, and then wearing it again. This is not always ideal or practical for every situation. If left unaddressed, the skin breakdown caused by continued prosthesis wear may impact quality of life and require additional clinic visits. Dr. Klute’s clinical trial aims to eliminate the need to remove and dry the prosthesis by evaluating which of the liner options best addresses socket perspiration. The anticipated results from the proposed project will help individuals with lower limb amputations make an informed decision on which liner best addresses their dermatological needs and give clinicians guidance on prescription of prosthetic liners to combat residual limb perspiration.

The successful use of a prosthesis for individuals with an amputation has a significant impact on daily living.3 Through their OPORP-funded work, Drs. Myers and Klute hope to broaden researchers’ and clinicians’ understanding of residual limb perspiration and offer insights into potential prevention and treatment options for prosthesis users. These two clinical trials may lead to improved quality of life for prosthesis users who suffer from residual limb perspiration, impact clinical practice guidelines, and allow physicians and patients to make better informed decisions.

References:

1Amputee Coalition. https://www.amputee-coalition.org/resources/limb-loss-statistics/

2Safari MR and Ghoseiri K. 2014. Prevalence of heat and perspiration discomfort inside prostheses: Literature review. Journal of Rehabilitation Research and Development 5(6):855-868.

3Smith DG, Lannan FM, Powell J, et al. 2021. Hyperhidrosis of the residual limb: A narrative review of the measurement and treatment of excess perspiration affecting individuals with amputation. Prosthetics and Orthotics International 45(6):477-486.

Links:

Abstracts for Dr Klute
Public and Technical Abstracts: Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration

Abstracts for Dr Myers
Public and Technical Abstracts: Clinical Effectiveness of Intrasocket Cooling on Incidence and Severity of Dermatological Conditions in Lower Limb Amputees


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