title: Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial.
abstract: A growing number of clinical trials and case reports support qualitative claims that use of an elevated vacuum suspension (EVS) prosthesis improves residual-limb health on the basis of self-reported questionnaires, clinical outcomes scales, and wound closure studies. Here, we report first efforts to quantitatively assess residual-limb circulation in response to EVS. Residual-limb skin health and perfusion of people with lower-limb amputation (N = 10) were assessed during a randomized crossover study comparing EVS with nonelevated vacuum suspension (control) over a 32 wk period using noninvasive probes (transepidermal water loss, laser speckle imaging, transcutaneous oxygen measurement) and functional hyperspectral imaging approaches. Regardless of the suspension system, prosthesis donning decreased perfusion in the residual limb under resting conditions. After 16 wk of use, EVS improved residual-limb oxygenation during treadmill walking. Likewise, prosthesis-induced reactive hyperemia was attenuated with EVS following 16 wk of use. Skin barrier function was preserved with EVS but disrupted after control socket use. Taken together, outcomes suggest chronic EVS use improves perfusion and preserves skin barrier function in people with lower-limb amputation.
  
  
  
  ClinicalTrials.gov; "Evaluation of limb health associated with a prosthetic vacuum socket system": NCT01839123; https://clinicaltrials.gov/ct2/show/NCT01839123?term=NCT01839123&rank=1.
authors.affiliation: Department of Surgery, Comprehensive Wound Center, and Dorothy M. Davis Heart and Lung Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH.
authors.forename: Cameron
authors.initials: C
authors.lastname: Rink
authors.affiliation: Ohio Willow Wood Company, Mt. Sterling, OH.
authors.forename: Matthew M
authors.initials: MM
authors.lastname: Wernke
authors.affiliation: Department of Biomedical Engineering, The Ohio State University, Columbus, OH.
authors.forename: Heather M
authors.initials: HM
authors.lastname: Powell
authors.affiliation: Department of Surgery, Comprehensive Wound Center, and Dorothy M. Davis Heart and Lung Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH.
authors.forename: Surya
authors.initials: S
authors.lastname: Gynawali
authors.affiliation: Ohio Willow Wood Company, Mt. Sterling, OH.
authors.forename: Ryan M
authors.initials: RM
authors.lastname: Schroeder
authors.affiliation: Department of Biomedical Engineering, The Ohio State University, Columbus, OH.
authors.forename: Jayne Y
authors.initials: JY
authors.lastname: Kim
authors.affiliation: Ohio Willow Wood Company, Mt. Sterling, OH.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Denune
authors.affiliation: Department of Surgery, Comprehensive Wound Center, and Dorothy M. Davis Heart and Lung Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH.|Department of Plastic Surgery, The Ohio State University Wexner Medical Center, Columbus, OH.
authors.forename: Gayle M
authors.initials: GM
authors.lastname: Gordillo
authors.affiliation: Ohio Willow Wood Company, Mt. Sterling, OH.
authors.forename: James M
authors.initials: JM
authors.lastname: Colvin
authors.affiliation: Department of Surgery, Comprehensive Wound Center, and Dorothy M. Davis Heart and Lung Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH.
authors.forename: Chandan K
authors.initials: CK
authors.lastname: Sen
mesh_terms: D000328:Adult; D000368:Aged; D000671:Amputation, Surgical; D000672:Amputation Stumps / Q000473:pathology*; D000674:Amputees; D001186:Artificial Limbs; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012867:Skin / Q000473:pathology*; D014618:Vacuum
keywords: amputation; elevated socket suspension; perfusion; prosthesis; residual limb; socket; suspension; transfemoral; transtibial; vacuum