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120                                HIGHSMITH ET AL.                                                                      RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES                     121



      and 6.3 cm  (control/suction socket group) compared   DISCUSSION                                         for prosthetists to educate patients regarding the risk   unilateral transtibial patients (five male, one female,
               2
      with mean initial wound areas of 3.6 cm  in estab-    The purpose of this review was to determine        of developing an ulcer as well as numerous methods   mean age = 66.5 years, mean weight = 94.6 kg) of
                                       2
      lished prosthesis users and 3.1 cm  in new prosthesis   the quantity, quality, and consistency of available   of preventing and managing them should they arise,   vascular (n = 5) and traumatic (n = 1) etiology pre-
                                 2
      users reported by Salawu et al. (9,10). Further, these   evidence to formulate evidence statements support-  including proper device utilization and volume man-  scribed VASS prostheses upon presentation with an
      wound area measures were made using vastly different   ing treatment methods for prosthesis-related RL   agement. Specifically, skin ulcers reportedly develop   open RL wound (20). Subjects had several comor-
      methodologies. For instance, there were manual mea-  ulcers. The review identified five articles (Table 3)   in nearly 27% of diagnosed skin problems in pros-  bidities, including Diabetes Mellitus Type 1 and 2,
      surements (10) and scaled on-screen measurements   that described the treatment of RL ulceration in 117   thetic users (14). The responsibility for preventing   peripheral vascular disease, Charcot joint disease,
      taken in software (9). These differences in wound area   amputee subjects. With the exception of four bilat-  and managing ulcers in the residual limbs of pros-  retinopathy, hearing impairment, dermatillomania,
      measurement methodologies further complicate the   erally involved individuals, subjects had a history   thetic users is shared between the prosthetist, who   and history of chronic alcohol and tobacco use. All
      ability to aggregate data for meta-analyses.   of unilateral transtibial amputation of vascular or       provides a properly fit device and educates the patient,   subjects received physiatrist-prescribed wound care
        Ultimately, prosthetic continuance or prosthetic   unknown etiologies. The subjects were mostly elderly   and the patient, who should practice diligent self-care   and were instructed to continue prosthetic use “as
      discontinuance were the predominant interven-  and had multiple comorbidities, including Type 2          and compliance.                              much as possible given any pain they may experi-
      tion options available to manage RL ulcers related   Diabetes Mellitus, coronary artery disease, hyperten-    Controversy exists as to whether continued   ence and not to limit their activities” (20). Vacuum
      to prosthetic use. Multiple adjuvant interventions   sion, hyperlipidemia, chronic venous insufficiency,   prosthetic use is indicated for amputees with RL   pump and prosthetic foot type were not controlled.
      were included within the themes of prosthetic con-  neuropathy, anemia, post-herpetic neuralgia, pru-    ulcerations because ambulation has many physio-  Wound size (determined by software analysis of ulcer
      tinuance (i.e., use) or discontinuance (i.e., disuse).   ritus, and chronic smoking. All subjects received   logical benefits that improve wound healing (15),   photographs) and time to complete wound closure
      These adjunct interventions included:                                                                    such as increased circulation (16), tissue oxygenation   were primary outcome measures. Wound surface
                                                    modification of prosthetic use, including restriction      (16,17), and fluid filtration (17). Prolonged inactiv-  area was 2.17 ± 0.65 cm  (initially) and mean time
                                                                                                                                                                                2
         1.  Prosthetic modification or adjustment  and disuse, as an intervention.                            ity, which is often associated with prosthetic disuse, is   to wound closure was 117 ± 113 d (range: 40 to 380
         2.  Planned progressive prosthetic re-introduction    The first empirical evidence statement (EES)    associated with several deleterious effects on health,   d). During that period, one subject was non-com-
         3.  Patient education                      addressed development of an ulcer relative to              including reduced functional capacity, respiratory   pliant with proper use protocols for a short time
         4.  Continued prosthetic use (VASS, suction, or   improper volume management and utilization of       function, skin integrity, and oxygen transportation   (≈20 d), another had a hole in the sealing sleeve that
           usual suspension) with wound care (during   interface components (Table 4). Scenarios that can      (17) as well as muscle atrophy (18). This list is not   required repair (at ≈100 d), and a third subject suf-
           disuse periods or scheduled)             contribute to ulceration include weight gain or loss,      inclusive of negative psychological effects of inactiv-  fered a fall requiring surgery and rehabilitation (at
                                                    changes in activity, medication and physiologic            ity, such as depression, anxiety, and psychosomatic
      Finally, three evidence statements were synthesized   changes, componentry damage, patient compliance                                                 ≈30 d). Authors concluded VASS prostheses may be
      from the results. The topics addressed were 1) ulcer                                                     fatigue (19).                                used while managing RL wounds in transtibial ampu-
      etiology, 2) continued prosthetic use, and 3) cessa-  issues, and improper patient education. Confidence     In the event that an ulcer develops, there are   tation patients. Results further suggest a well-fitting
                                                    in this statement was moderate. It is standard practice
      tion of prosthetic use (Table 4).                                                                        numerous management options, including pros-  VASS socket does not preclude RL wound healing
                                                                                                               thetic use or disuse. EES 2 (Table 4) indicates that,   and closure in compliant users even without activity
                                                                                                               in the absence of comorbidities that may delay healing   limitation (20). This recently published data sup-
                                                                                                               and impair cognition, patient education and modi-  ports EES 2 and suggests that continued prosthetic
      Table 4. Empirical Evidence Statements                                                                   fied prosthetic use with or without elevated vacuum   use without activity restrictions may be possible in
       Table 4. Empirical Evidence Statements
                                                                                                               suspension is safe, can reduce ulcer size, and result   the presence of common diabetic-related complica-
                                                                  Level of
              Empirical Evidence Statement   Supporting Studies                 Category                       in limited but continued function during healing.   tions when VASS is utilized. It further suggests that,
                                                                 Confidence
       Improper volume management and utilization of   Bruno & Kirby (2009) [Moderate]                         Conversely, EES 3 (Table 4) indicates that prosthetic   on a per-case basis, comorbidities do not preclude
       interface components can result in ulceration to the   Highsmith & Highsmith (2007)    Moderate   Ulcer etiology   disuse with or without alternative interventions such
       skin of the residual limb.        [Moderate]                                                                                                         continued prosthetic use in the presence of a resid-
                                                                                                               as surgery or systemic antibiotics may be indicated   ual limb ulcer.
       Following development of an ulcer, in the absence of  Bruno & Kirby (2009) [Moderate]                   in the case of residual limbs that ulcerate in the pres-
       comorbidities that delay healing and impair   Highsmith & Highsmith (2007)
       cognition, patient education and modified prosthetic   [Moderate]                                       ence of chronic heavy smoking, intractable pain, rapid   Limitations
       use with or without elevated vacuum suspension is   Salawu et al. (2006) [High]   Moderate   Continued prosthetic use   volume and weight change, history of chronic ulcer-    Though most included articles demonstrated
       safe, can reduce ulcer size, and result in limited but   Trabellesi et al. (2012) [High]
       continued function during healing.                                                                      ation, systemic infections, or advanced dysvascular   moderate to high internal validity and high exter-
       Prosthetic disuse and/or alternative interventions   Karakos (2006) [Moderate]                          etiology. The confidence in both statements is mod-  nal validity, only one randomized control trial was
       such as surgery or systemic antibiotics, may be   Highsmith & Highsmith (2007)                          erate based on available evidence.           included. This indicates substantial need for more
       indicated in the case of residual limbs that ulcerate in  [Moderate]
       the presence of chronic heavy smoking, intractable        Moderate   Cessation of prosthetic use          An additional case series, published after conduct-  high-quality research including more randomized
       pain, rapid volume and weight change, history of                                                        ing this review, reported on continued prosthetic use   control trials to determine the optimal treatment
       chronic ulceration, systemic infections, or
       dysvascular etiology.                                                                                   in ulcerative care.  Hoskins et al. described six (n = 6)   methods to reduce wound healing time and increase
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