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118 HIGHSMITH ET AL. RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 119

Table 2. Internal and External Validity of Included Studies
Table 2. Internal and External Validity of Included Studies These two steps resulted in the elimination of 2,956 of 61.8 years (range: 44 to 80 years) who completed
External articles. A further 46 articles were excluded following their respective studies. Eight subjects did not com-
Study Internal Validity Validity abstract review. Full text articles were obtained and plete their studies, so attrition was 6% when all five
Study
Design 1- 10- 1- reviewed for the remaining 22 references. Of these, studies were considered. The majority of subjects were
4 5 6 7 8 9 11 12 13 14 15 16 17 18 TOTAL 8 TOTAL 17 were excluded based on eligibility criteria. The male (74%) and unilaterally involved at the transtib-
Bruno & remaining five articles (Table 3) were included in the ial level. Only four subjects were bilaterally involved.
Kirby O6 NA NA    Mod  High evaluation and synthesis. All studies were clinically Most subjects sustained their amputation as a result
(2009)
Karakos O6 NA NA Low High oriented, including one randomized-control trial (9), of peripheral vascular disease. At least three comor-
(2006)     one observational cohort study (10), one case series bid diagnoses, but as many as eight comorbidities,
Highsmith (5), and two case studies (11,12). None of the included were reported in some cases. Most ulcers were clas-
& O5 Mod High studies incorporated blinding nor reported effect size. sified as stage II level (13), and the leading diagnostic
Highsmith NA NA     
(2007) All studies addressed accommodation and washout methodology was history and physical examination.
Salawu et and were free of conflicts of interest. Also, attrition In some cases, the physical examination was aug-
al. (2006) O1 NA NA         High  High was addressed in all studies and was <20%; however, mented with either wound measurement or Duplex
Trabellesi attrition rates were not equal among groups due to imaging. Two dependent variables—time to wound
et al. E1  NA           High  High the inclusion of case studies. Only valid and reliable healing and wound size (or area)—have the prom-
(2012)
outcome measures were used in the included studies. ise of aggregation and synthesis. Unfortunately, due
One study addressed the AAOP instrument’s fatigue
to reporting at an apparently preset follow-up date,
NA is not an available criteria for the indicated study type. Blank spaces indicate the criteria was not identified whereas “•” indicates the and learning criteria. Statistical analysis was appro- rather than at the date of complete healing, wounds
NA is not an available criteria for the indicated study type. Blank spaces indicate the criteria was not
criteria was observed. Mod is moderate.
identified whereas “” indicates the criteria was observed. Mod is moderate. priate, adequately powered, and reported in two of were in various stages of healing upon follow-up.
the five studies. Additionally, exclusion criteria were Therefore, time to healing data could not be aggre-
not discussed in three of the five included studies. gated. Time to healing or time to follow-up were
Finally, since all articles had high external validity, widely varied, with a range from two to 20 weeks.
Figure 1. Study flow diagram and elimination process.
total confidence in the synthesized evidence state- Regarding wound size, the wounds in the Traballesi
ments were predominantly in accordance with the
et al. study (9) were nearly two times the size of those
Articles identified through database searching:
Identification (n=3,024) Articles Eliminated from internal validity ratings. reported in the Salawu et al. study (10). Traballesi
et al. reported mean initial wound areas of 7 cm
In total, conclusions from this report were made
2
from 117 subjects with a mean (interquartile) age
Title Screening
(Vacuum Assisted Suction Suspension (VASS) group)
Table 3. Study Design, Intervention (Use versus Disuse), Demographics, Outcome Measures, Evidence Quality
Articles potentially available (n=2,956) Table 3. Study design, Intervention (Use vs. Disuse), Demographics, Outcome Measures, and Evidence Quality
Overall
for classification of pertinence Study Design* Intervention Sample Age (y) Outcome Measures Quality of
Study
Mean
Screening (n=68) Articles Eliminated from proper use of silicone liners otherwise FIM, Ulcer measurements, Evidence
Size
Use/Disuse
Use, 6 hours per day
Abstract Screening
(n=46) Bruno & Kirby (2009) O6 they will lead to pressure sores. 1 84 Silicone use/disuse for ulcer Moderate
prevention
Ulcer healed 4 months d/c
Articles deemed appropriate Karakos (2006) O6 Disuse. additional interventions: surgery 1 64 Duplex scan Moderate
Eligibility for Full Evaluation Articles Eliminated from 6 months due to pain and ulceration
(Angioplasty)
(n=22)
Case 1: Use, 4 hours per day
Case 2: Disuse, 1 month +
Full Review Highsmith & O5 Case 3: Use, with frequent adjustments 5 45 Returned to independent Moderate
Highsmith (2007)
ambulation and function
Case 4: Disuse 1 week
(n=17) Case 5: Use with wound protection
Articles Included Salawu et al. (2006) O1 Use of prosthetic device with healing 102 60 Changes in surface area of High
Included (n=5) Use of prosthetic device, VAS vs Suction demographics, locomotor
ulcers and photographs,
ulceration
wound cultures
Trabellesi et al.
(2012) E1 socket system following ulcers/wounds 20 61 capability index, visual High
healing. 12 weeks analogue scale