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RESIDUAL LIMB ULCER MANAGEMENT IN LEG AMPUTEES 119

These two steps resulted in the elimination of 2,956 of 61.8 years (range: 44 to 80 years) who completed
articles. A further 46 articles were excluded following their respective studies. Eight subjects did not com-
abstract review. Full text articles were obtained and plete their studies, so attrition was 6% when all five
reviewed for the remaining 22 references. Of these, studies were considered. The majority of subjects were
17 were excluded based on eligibility criteria. The male (74%) and unilaterally involved at the transtib-
remaining five articles (Table 3) were included in the ial level. Only four subjects were bilaterally involved.
evaluation and synthesis. All studies were clinically Most subjects sustained their amputation as a result
oriented, including one randomized-control trial (9), of peripheral vascular disease. At least three comor-
one observational cohort study (10), one case series bid diagnoses, but as many as eight comorbidities,
(5), and two case studies (11,12). None of the included were reported in some cases. Most ulcers were clas-
studies incorporated blinding nor reported effect size. sified as stage II level (13), and the leading diagnostic
All studies addressed accommodation and washout methodology was history and physical examination.
and were free of conflicts of interest. Also, attrition In some cases, the physical examination was aug-
was addressed in all studies and was <20%; however, mented with either wound measurement or Duplex
attrition rates were not equal among groups due to imaging. Two dependent variables—time to wound
the inclusion of case studies. Only valid and reliable healing and wound size (or area)—have the prom-
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,
and learning criteria. Statistical analysis was appro- rather than at the date of complete healing, wounds
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.
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
internal validity ratings. reported in the Salawu et al. study (10). Traballesi
In total, conclusions from this report were made et al. reported mean initial wound areas of 7 cm
2
from 117 subjects with a mean (interquartile) age (Vacuum Assisted Suction Suspension (VASS) group)
Table 3. Study design, Intervention (Use vs. Disuse), Demographics, Outcome Measures, and Evidence Quality
Table 3. Study Design, Intervention (Use versus Disuse), Demographics, Outcome Measures, Evidence Quality
Overall
Study Intervention Sample Mean
Study Outcome Measures Quality of
Design* Use/Disuse Size Age (y)
Evidence
Use, 6 hours per day
proper use of silicone liners otherwise FIM, Ulcer measurements,
Bruno & Kirby (2009) O6 they will lead to pressure sores. 1 84 Silicone use/disuse for ulcer Moderate
Ulcer healed 4 months d/c prevention
Disuse. additional interventions: surgery
Karakos (2006) O6 (Angioplasty) 1 64 Duplex scan Moderate
6 months due to pain and ulceration
Case 1: Use, 4 hours per day
Case 2: Disuse, 1 month +
Highsmith & O5 Case 3: Use, with frequent adjustments 5 45 Returned to independent Moderate
Highsmith (2007) ambulation and function
Case 4: Disuse 1 week
Case 5: Use with wound protection
Changes in surface area of
Use of prosthetic device with healing
Salawu et al. (2006) O1 102 60 ulcers and photographs, High
ulceration
wound cultures
Use of prosthetic device, VAS vs Suction demographics, locomotor
Trabellesi et al. E1 socket system following ulcers/wounds 20 61 capability index, visual High
(2012)
healing. 12 weeks analogue scale