Vol. 48 - No. 4 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 613

Residual limb wounds or ulcers heal in transtibial amputees using an

active suction socket system.A randomized controlled study

difference between VASS-users (80, range: 0-112 hours a weeks) and control-users (59, range: 0-91) was no longer significant (p=0.191). Despite more intense use of the prosthesis, pain and wound healing did not sig-nificantly differ between the two groups.Conclusion. These results showed that the VASS pros-thesis allowed early fitting with prompt ambulation recovery without inhibiting wound healing or increas-ing pain. Key words: Amputation - Prosthesis implantation - Rehabilita-tion - Wound healing.

Lower limb amputation (LLA) is a surgical proce-dure that has been performed for centuries. To-

day, it is the end point of surgical treatment for dys-vascular patients and the beginning of rehabilitation aimed at restoring mobility with a prosthesis.1, 2

The high cost of the intervention, from amputa-tion to one-year post rehabilitation necessitates care-ful selection of appropriate candidates for prosthetic rehabilitation who have the ability to benefit most from new prosthetic technology. Many studies have attempted to identify indicators of successful pros-thetic outcome following LLA. Most of the indicators have focused on clinical factors such as age, comor-bidity, cause and level of amputation.3, 4

Transtibial (TT) residual limb amputees have shown an higher mobility compared to transfemoral

Background. The factors that determine successful rehabilitation after lower limb amputation have been widely investigated in the literature, but little atten-tion has been paid to the type of prosthesis and clini-cal state of the residual limb, particularly the presence of open ulcers.Aim. The aim of this study was to investigate the ef-fects of a vacuum-assisted socket system (VASS) in a sample of trans-tibial amputees with wounds or ul-cers on the stump and to evaluate prosthesis use as a primary outcome. Secondary outcome measures were mobility with the prosthesis, pain associated with prosthesis use, and wound/ulcer healing. Study design. Randomized controlled study.Setting. Inpatient.Population. Twenty dysvascular transtibial amputees suffering from ulcers due to prosthesis use or delayed wound healing post-amputation were enrolled.Methods. Participants were separated into two groups: the experimental group was trained to use a VASS prosthesis in the presence of open ulcers/wounds on the stump; and the control group was trained to use a standard suction socket system prosthesis following ulcers/wounds healing.Results. At the end of the 12-week rehabilitation pro-gram, all VASS users were able to walk independently with their prosthesis as reflected by a median Locomo-tor Capability Index (LCI) value of 42, whereas only five participants in the control group were able to walk independently with a median LCI value of 21. At the two-month follow-up, the participants used their VASS prostheses for 62 hours a week (median; range: 0-91), which was significantly longer than the control group using the standard prosthesis for 5 hours per week (range: 0-56, p=0.003). At the six-month follow-up, the

1Fondazione Santa Lucia IRCCS, Rome, Italy2ITOP, Officine Ortopediche, Rome, Italy

EUR J PHYS REHABIL MED 2012;48:613-23

M. TRABALLESI 1, A. S. DELUSSU 1, A. FUSCO 1, M. IOSA 1, T. AVERNA 1, R. PELLEGRINI 2, S. BRUNELLI 1

Corresponding author: S. Brunelli, Fondazione Santa Lucia - IRC-CS, via Ardeatina 306, 00179 Rome, Italy. E-mail: s.brunelli@hsantalucia.it

Anno: 2012Mese: ??Volume: 48No: 1Rivista: EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINECod Rivista: EUR J PHYS REHABIL MED

Lavoro: 2669-EJPRMtitolo breve: Residual limb wounds or ulcers heal in transtibial amputeesprimo autore: TRABALLESIpagine: 613-23

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TRABALLESI RESIDUAL LIMB WOUNDS OR ULCERS HEAL IN TRANSTIBIAL AMPUTEES

614 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE December 2012

of the pressure and shear forces involved in the prosthetic socket interface 19 and because of com-promised skin integrity due to increased moisture and the prolonged moist exposure to the chemical compounds of the prosthesis.8

A new trend in the management of unhealed stumps after amputation surgery (defined by the authors as a wound larger than 1 cm2 later than 3 weeks after surgery) has been proposed by Van-Ross et al. by means of a Pneumatic Post-Amputa-tion Mobility Aid (PPAM).18 In this observational co-hort study, the authors investigated a procedure that consisted of an early mobilization of the amputees with this device for about 3 to 6 weeks, even in presence of a residual limb wound. After the PPAM training the patients were fitted with a standard TT socket using a 2-sock fit, a sleeve or a cuff strap as suspension. The complete wound healing was achieved in 74% over a mean of 141 (87-270) days but the mobility outcomes along the training were not reported.

Recently, the case of a patient with TT amputation was reported who, despite the presence of an open residual limb wound with a surface area of about 43 cm2, was fitted a vacuum-assisted socket system (VASS) prosthesis.12 After four months of daily VASS prosthesis use, a trend towards marked reduction of the wound area (about 34%) was observed. In fact, the patient was able to walk without pain and his in-dependence in activities of daily living improved im-mediately. This total surface bearing socket system consists of a polyurethane liner, a suspension sleeve and an air evacuation pump, which creates the vacu-um between the liner and the inner socket wall. The vacuum promotes a natural fluid exchange, which regulates volume fluctuation in the residual limb, reduces stress on the residual limb and increases suspension. Use of the VASS influences the pressure on the residual limb during ambulation by reducing the fluid forced out during stance and increasing the amount of fluid drawn into the limb during swing phase.20 Therefore, the change in pressure (vacuum condition) may be supporting the healing process of stump wounds. It has been proven that the use of vacuum therapy is successful in treating complex diabetic foot wounds.21

Until now, no longitudinal clinical studies have been carried out to analyze the problems or ben-efits associated with VASS use in amputees affected by ulcers or unhealed residual limb wounds. There-

amputees,5 but they had a four-time greater risk of developing skin problems.6 This may be caused by higher bony prominences and increased pressure during ambulation.7 The clinical condition of the re-sidual limb is a crucial factor. Poor stump condition can interfere with rehabilitation, prolong the need for care, and delay expected outcomes 8 whereas good residual limb condition is a major determinant of mobility.9

Rehabilitation success may also depend on the outcome of prosthesis fitting. In fact, prosthesis fit-ting is the only way patients with LLA can regain the ability to walk and find new independence in the activities of daily living (ADL). Restrictions or delays in rehabilitation can lead to a deterioration of balance,10 muscle endurance, strength, flexibility and coordination 11, resulting in a debilitating cy-cle.12 Moreover, delayed prosthetic fitting is the main cause of increased costs of rehabilitation after ampu-tation.13 Nevertheless, to be able to fit the prosthesis the stump has to meet certain criteria: the surgical wound must be healed; the edema should be re-solved; the residual limb should be conically shaped and mature.14 The literature reports a prevalence of residual limb wounds or ulcers varying from 26.7% 6 to 8.8%.15 Meulenbelt investigated 805 Dutch lower limb amputees using a questionnaire: 57% reported to have suffered from pressure ulcers and 31% from wounds more than 1 month prior to completing the questionnaire.8

One question that needs to be answered, how-ever, is whether the presence of an open surgical wound or ulcers due to the prosthetic use precludes the use of a prosthesis.16 Berke reported that the presence of a surgical wound does not necessarily preclude weight bearing even if it needs a repeated wound assessment and, eventually, a modification of the prosthetic socket.17 On the other hand, no es-tablished treatment protocols exist if the stump fails to heal,18 and no randomized trials are available to determine if the type of prosthesis might be associ-ated with skin problems.6

Salawu et al. reported that continued prosthetic use was possible even in patients with LLA with re-sidual limb ulcers (mean size 3.3 cm2) or delayed primary wound healing, and that it was associated with a significant reduction in ulcer size.19 Neverthe-less, they noted deterioration in 10% of cases which led to an interruption of rehabilitation training. Pros-thesis users may also develop stump ulcers because

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Vol. 48 - No. 4 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 615

hiscence as a surgical complication or an ulcer due to localized pressure from a poorly fitting prosthetic socket as reaction to repetitive mechanical stress (fol-lowing the classification proposed by Bui 22); age between 18 and 80 years; absence of severe comor-bidities that would prevent completion of the reha-bilitation program (such as: renal/liver failure; ankle systolic index <0.6 on the sound limb, measured by Doppler, hemiparesis or neurological impairment, fixed flexion contracture of the knee or hip joints that would prevent prosthesis fitting, severe arthritis); sta-ble clinical condition; intact mental status; and Medi-care Functional Classification Level K-2 or K-3.23 We also excluded amputees suffering from phantom limb pain because it negatively affects the rehabilitation

fore, the aim of this study was to investigate the effects of VASS in a sample of amputees with these lesions on the stump. We were particularly inter-ested in length of prosthetic use, mobility, pain and wound healing.

Materials and methods

A randomized controlled trial with 20 patients with dysvascular transtibial (TT) amputation was per-formed. All patients with dysvascular TT amputation consecutively admitted to our rehabilitation hospital who met the following inclusion/exclusion criteria were enrolled in the study: presence of a wound de-

Figure 1.—Study flow-chart diagram.

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TRABALLESI RESIDUAL LIMB WOUNDS OR ULCERS HEAL IN TRANSTIBIAL AMPUTEES

616 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE December 2012

a one-way check valve with a vacuum pump con-nected to a shock absorber. The residual limb is not directly exposed to this subatmospheric pressure because the vacuum is contained between the liner and the inner wall of the socket by the suspension sleeve.20

The CG was fitted a standard suction socket (SS) with a one-way air expulsion valve. This kind of prosthesis has no active vacuum system and is gen-erally used only by patients whose residual limb wounds are close to full healing. For all CG par-ticipants we used the same liner, the same one-way valve, and the same sleeve. Both groups used a dy-namic elastic response prosthesis foot.

Wound treatment

No wound dressings were applied while using the prostheses. After prosthetic use, the biological secre-tion remained inside the liner; after removing it, it was washed with water and topical antiseptic by the team nurse. In VASS group wound dressings were applied during the night time. Medication was ad-ministered with topical antiseptics or silver sulfadi-azine (Sofargen®) if the wound was deep. Necrotic tissue was excised if necessary. The same medica-tion was used in both groups. When we suspected that a wound was infected, we took a deep speci-men for bacterial culture and antibiotic sensitivity testing and, if necessary, administered the appropri-ate systemic antibiotics. A physician inspected the lesions twice a week and a consultant plastic sur-geon twice a month.

Rehabilitation

A 12-week rehabilitation program was planned for both groups starting a few days after amputation or, in previous prosthesis users, after the occurrence of a new stump wound.

Individual physical therapy was performed for 60 minutes, twice a day, 5 days a week. The prosthetist was available twice a week to check the prosthesis and make necessary adjustments.

Data collection

Clinical data were collected throughout the 12-week rehabilitation program: at baseline (W0), af-ter one (W1), two (W2), three (W3), four (W4), six

outcome.24 A physician team assessed the residual limb skin problems and the clinical/mental condition before enrollment (Figure 1).

The enrolled subjects were randomly assigned to either the VASS Group (intervention group, VAG) or the standard suction socket group (control group, CG). A simple randomization with a 1:1 allocation ratio was used: Patients were asked to select one of two sealed envelopes from a box containing a piece of paper with the assignment in one of the two groups, which was concealed until the enve-lope was opened.

Prosthesis

All participants (VAG and CG) were fitted with a modular total surface weight-bearing (TSB) socket made by plaster casting technique, as defined by Fergason and Smith.25 All the prostheses were fab-ricated by the same certified prosthetist with more than 20 years of experience, and were carefully checked and adjusted. The shape of this socket provides a more uniform distribution of pressure across the stump and reduces shear forces as com-pared to patellar tendon bearing sockets.25 The sus-pension system used in the VAG was the VASS TEC Harmony® (Otto Bock HealthCare GmbH, Dud-erstadt, Germany), in which the vacuum-assisted condition is created by drawing -69 kPa through

Figure 2.—An example of the technique adopted to assess the area and the perimeter of the wounds by means of the free software J-MacroVision vl 1.2.7 (The area is defined by means of the 63 black dots).

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Vol. 48 - No. 4 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 617

tool was used to assess the size of the ulcers/wounds.

Locomotor capabiLity index (Lci)

Ambulatory skills were evaluated by means of the LCI.26 This index measures locomotor capabilities with the prosthesis during and after rehabilitation. The LCI grades the patient on seven basic and seven advanced ambulatory activities using a scale rang-ing from 0 to 3; the maximum total score is 42. A higher score indicates a better level of locomotor independence. We used the items of the Italian Ver-sion.27

VisuaL anaLogue scaLe (Vas)

The VAS is a simple, sensitive and reproducible tool in which participants express their pain inten-sity in numerical values. It consists of a line, 10 cm long; the ends of which are labeled with the two extremes (i.e., “no pain” and “pain as bad as I can imagine”); the rest of the line is blank. The patient is asked to put a mark on the line describing the

(W6), eight (W8) and twelve weeks (W12). Fol-low-up visits were carried out two months (12+8 weeks, W20), four months (12+16, W28) and six months (12+24, W36) after the completion of the rehabilitation program. Thus, the total observation period of the study was 36 weeks, as shown in Table I.

Outcome measures

Socio-demographic and clinical data were col-lected throughout the 36-week study. The number of hours of prosthesis use per week at 2, 4 and 6 months after completion of the rehabilitation pro-gram was the primary outcome measure. This was assessed by asking the participants specific ques-tions: 1) How many days per week do you use the prosthesis? 2) How many hours per day do you use the prosthesis? In addition, specific tools to measure walking capabilities with the prosthe-sis (Locomotor Capability Index), and pain per-ception (Visual Analogue Scale) were used at dif-ferent points of the follow-up, according to the study design (Table I). Moreover, a computerized

tabLe I.—Timing and description of assessment.

TIming Assessment

W1 – 1 week after enrollment Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment, digital photographs

W2 - 2 weeks after enrollment Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment

W3 - 3 weeks after enrollment Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment

W4 – 4 weeks after enrollment Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment

W6 – 6 weeks after enrollment Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment

W8 - 8 weeks after enrollment Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment

W12 – 12 weeks after enrollment – completion of the rehab program

Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment, digital photographs, walking capabilities (LCI)

W20 – 20 weeks after enrollment (2 month FU after the completion of the rehab program)

Monitoring and clinical assessment of open wounds, clinical evaluation of possible infections and treatment, digital photographs, prosthesis use (hours per week), walking capabilities (LCI), pain (VAS)

W28 - 28 weeks after enrollment (4 month FU after the completion of the rehab program )

Monitoring and clinical assessment of the open wound, clinical evaluation of possible infections and treatment, digital photographs, prosthesis use (hours per week), walking capabilities (LCI), pain (VAS)

W36 - 36 weeks after enrollment (6 month FU after the completion of the rehab program )

Monitoring and clinical assessment of the open wound, clinical evaluation of possible infections and treatment, digital photographs, prosthesis use (hours per week), walking capabilities (LCI), pain (VAS)

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TRABALLESI RESIDUAL LIMB WOUNDS OR ULCERS HEAL IN TRANSTIBIAL AMPUTEES

618 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE December 2012

ney U-test and their variations over time for each group were analyzed using Friedman’s analysis. The number of independent vs. dependent walkers in the two groups was compared using the c2-test.

Finally, a Kaplan-Meyer curve was plotted to highlight the rate of patients with completely healed wounds (100%) in the VAG and CG, using the log rank test to determine whether healing was distrib-uted equally between the two groups.

The ethical committee of the Fondazione Santa Lucia, Rome, Italy, approved this study (Prot. CE-AG4-PROG.92-136), and the subjects gave their writ-ten informed consent to participate.

Results

Twenty subjects were enrolled to this study with an average age of 61.3±13.2 years, 17 men and three women. In ten patients the amputation wound had not healed; five of these patients were randomly as-signed to the VAG and five to the CG. The other ten patients had already been using a prosthesis on a daily basis but suffered from dermal ulcers; five of these patients were randomly assigned to the VAG and five to CG. The two groups did not differ for age (P>0.05, t-test) or gender (1 woman in VAG, 2 in CG).

Patients in the VAG were able to take their first steps with the prosthesis 16.4±8.6 days after starting the protocol. At the end of the rehabilitation pro-gram, all VAG patients were able to walk with their prosthesis. Their median LCI-score was 42 which is the maximum score for this mobility index (Figure 3).

Conversely, patients in the CG waited for sub-stantial wound healing (i.e.: wound area equal to or

intensity of his/her pain. The distance between that mark and the beginning of the line is measured to obtain the patient’s score.28

Wound/Ulcer dimension

Digital photographs of the participants’ residual limbs were taken at specific time points to docu-ment wound healing (Table I). Documentation re-quires five digital pictures of the entire limb. We recorded the following data: localization, descrip-tion, type and dimension of wound healing, skin ulcers, scars and necrosis. To assess the progress of wound healing, we assessed the area and pe-rimeter of the wound using the free software J-Mi-cro Vision vl 1.2.7.29 The image plan of the photos included the wound and a scaled tape for refer-ence. An example of this technique is reported in Figure 2.

Statistical analysis

Continuous measures (age, length of prosthesis disuse, time of prosthesis use per week, area and perimeter of wounds) are reported as means and standard deviations and the two groups were com-pared using a two-tailed unpaired t-test. A full analy-sis of variance was performed on hours of prosthe-sis use per week between the types of prostheses (VAG vs. CG) as between-subject factor, and the dif-ferent assessment timing (W12, W20, W28, W36) as within-subject factor.

Scores of clinical scales (LCI, VAS) are reported as medians with first and third quartiles depict-ing the interquartile range in which the mean 50% of individual values are found. The scores of the two groups were compared using the Mann-Whit-

tabLe II.—Characteristics of the two groups of participants (VAG: VASS Group, CG: control group): age (mean ± standard deviation), gender (males and females), initial wound area (mean, minimum and maximum), time until prosthesis fitting (mean ± standard deviation), number of patients with prosthesis at the end of protocol and relevant LCI-score (median, first and third quartiles).

Group Age Gender Initial wound area (cm2)

Time until prosthesis

fitting

After completion of the 12-week rehab program

Number of patients able to walk independently

LCI score

VAG 55±14 9 M, 1 F 7.0 (0.2; 38.3) 16.4±8.6 10 out of 10 42 (39; 42)CG 66±11 8 M, 2 F 6.3 (0.9; 33.1) 58.6±24.7 5 out of 10 21 (20; 31)

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Vol. 48 - No. 4 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 619

drop-outs. The median values for VAG vs. CG were 41 vs. 26 (P=0.387) at W20; 38 vs. 29 (P=0.874) at W28; and 40 vs. 26 (P=0.138) at W36 (Figure 3).

During the follow-up period after completion of the rehabilitation program, one patient in the VAG discontinued the use of the prosthesis be-cause of pain at W20 and did not resume its use. The LCI-scores of the other nine subjects in the VAG remained stable over the following six months (c2=3.63, P=0.305).

Three patients dropped out of the CG: one be-cause of the absence of a caregiver that could help him to participate to the evaluations (out after 6 weeks of follow-up), one because of loss of moti-vation (out at 4 month follow-up) and one due to a dysvascular amputation of the same limb, which converted him into a transfemoral amputee (out after 4 weeks of follow-up). Two of these patients were non-prosthesis users at the end of the reha-bilitation program, and the other one had an LCI-score of 5. Nevertheless, two patients in the CG started to walk independently with their prosthesis after W12: one at W20 (LCI-score=41) and one at W36 (LCI-score=22). Another patient did not use his prosthesis at W24 because of pain due to the creation of a new stump wound, but he used it at W20 and W36.

A repeated-measure analysis of variance per-formed on hours of prosthesis use per week was used to investigate this primary outcome measure

less than 1 cm2, adhered lips, absence of infection and sanguineous secretion) before they were able to walk with their prosthesis. The time until prosthe-sis fitting was 58.6±24.7 days and thus significantly longer (P=0.012, t-test) than that needed in the VAG. Moreover, at completion of the rehabilitation pro-gram in W12, only five patients in the CG were able to walk independently with a median LCI-score of 21 (Figure 3).

At the end of the rehabilitation program, the number of patients who were able to walk inde-pendently with their prosthesis (c2=6.67, P=0.001) and the corresponding LCI-scores (P=0.002 Mann-Whitney U-test) differed significantly in favor of the VAG.

These results and the characteristics of partici-pants are summarized in Table II.

In addition, at all follow-ups a better clinical mo-bility was observed in the VAG as compared to the CG, even if the difference no longer reached statis-tical significance due to an increasing number of

42

35

28

21

14

7

0End of rehab. 2-m. f-up 4-m. f-up 6-m. f-up

LC

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VAG CG

Figure 3.—Box-plot of LCI-scores for VAG (empty boxes) and CG (grey boxes): the boxes show the lower quartile, median (bold line), and upper quartile values, the whiskers represent the most extreme values within 1.5 times the interquartile range from the ends of the box, the circles represent the outliers (data with values beyond the ends of the whiskers). Mann-Whitney u-tests showed a significant difference between the two groups at the end of the rehabilitation program (P=0.002), but no longer at follow-ups: (at two-months P=0.387, at four months: P=0.874; at six-months: P=0.138).

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Use

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Figure 4.—Top panel: Mean and standard deviation of the use of prosthesis at the three follow-ups for VAG (black) and CG (grey) in terms of hours per week. A t-test showed a significant difference between the two groups at two-months (P=0.001), but neither at four- (P=0.275) nor at six-month (P=0.184) follow-up.

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TRABALLESI RESIDUAL LIMB WOUNDS OR ULCERS HEAL IN TRANSTIBIAL AMPUTEES

620 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE December 2012

no longer at 4-months (median value: 65 [0-105] vs. 59 [0-105], P=0.275) and at 6-month follow-up (median value: 80 [0-112] vs. 59 [0-91], P=0.184) (Figure 4).

Nevertheless, prosthesis use in the VASS group remained markedly higher than that in the CG throughout the entire follow-up period and may be considered clinically relevant.

Despite the more intense prosthesis use of the patients in the VAG, pain while using the pros-thesis did not significantly differ between the two groups at W20 (P=0.813, Mann-Whitney U-test), W28 (P=0.475) and W36 (P=0.962). The median VAS scores were 5.0 (3.4-6.4) and 3.1 (2.2-5.9) at W20 and slightly reduced to 3.7 (1.3-5.4) and 2.6 (1.1-5.8) at W36 in the VAG and CG, respectively. However, this slight reduction was not statistically significant (P=0.417 for VAG, p=0.368 for CG; Friedman’s analy-sis).

High variability among participants was recorded for area and perimeter of wounds. The mean wound area in the VAG at W1 was 7 cm2 (range 0.2-38.3 cm2). It was not significantly different from that re-corded in the CG with 6.3 cm2 (range 0.9-33.1 cm2; P=0.877, t-test). It should be noted that the VASS

of the study. The statistical analysis revealed a sig-nificant effect of the type of prosthesis (VAG vs. CG, F1,15=4.78, P=0.045) and the point of follow-up (F2,30=4.83, P=0.015) in our sample (10 patients in the VAG vs. 7 in the CG, considering 0 hours for non-users); however, the interaction between these two factors fell short of the significance threshold (F2,30=2.74, P=0.081). This last non-statis-tically significant result was due to increased use of the prosthesis in the CG subjects between W20 and W24.

At the two-month follow-up, we found that the participants used their VASS prostheses for a mean of 62 hours a week (median: 66, range: 0-91), which was significantly longer than the control group us-ing the standard prosthesis for a mean of 12 hours per week (median: 5; range: 0-56, P=0.003), but

100

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Rat

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Figure 5.—Percentage rate of wound healing in terms of perimeter (top plot) and area (down plot) in respect of time for VAG (black) and CG (grey).

Figure 6.—Kaplan-Meier plot reporting the rate of patients with wound still not healed in respect of time for VAG (black) and CG (grey).

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Vol. 48 - No. 4 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE 621

tive approach is due to the fact that actually no evidence is available in medical literature which mostly supports one out of two possible solu-tions: namely leaving the prosthesis off until proper healing has occurred versus continuing use of the prosthesis.16

At the same time, the use of VASS prosthesis did not inhibit wound healing and it did not increase pain while using the prosthesis in the VAG.

As Van Velzen et al. have pointed out, many studies on early prosthesis fitting in the presence of unhealed wounds have demonstrated both pos-itive and negative results, without any clear state-ment about effectiveness.14 Salawu et al. observed that continued use of the prosthesis, also in the presence of an unhealed wound, was associated with a significant reduction in ulcer size.15 How-ever, the mean size of the ulcers in their patient group was only 3.3 cm2 (range 0.06-81 cm2) at baseline, which was less than half of the wound size in our study groups. Furthermore, the dete-rioration in the study of Salawu is comparable with the deterioration rate in the VASS group of our study (both 10%). However, neither the type of prosthesis (socket shape, suspension system) nor its needed progressive adaptations were de-scribed in the Salawu’study.16 Probably the answer to the question whether early prosthesis fitting can be effective depends on the methodology used. Besides the methodology used, the sample size may also be of influence. The results of this study show that a prosthetic system with an active vacuum suspension system allows for safe use of the prosthesis.

Board et al. demonstrated that VASS prevented daily volume loss of the stump, which occurs in a regular socket, and reduced pistoning and shear stress of the residual limb in the socket resulting in minimization of skin irritations and breakdown.30 Moreover, VASS also allows for maintaining more oxygenated fluids in the residual limb.20 All these features could explain why pain was not higher in the VAG in spite of the use of their prosthesis in the presence of unhealed wounds, for longer periods of time and with better functional out-comes than the CG patients. Furthermore, the VAG showed a trend to faster wound healing than the CG, although the difference was not statistically significant.

The above reported study of VanRoss 18 supports

prosthesis was given to the patients before the third assessment of wound healing, whereas the stand-ard SS prosthesis was given only if the wound was close to complete healing. Due to this high vari-ability in terms of area and perimeter of wounds, the differences between groups were not statisti-cally significant. However, as shown in Figure 5, the mean wound healing rate, expressed as percentage of reduction of both wound area and perimeter, was quite faster in the VAG from W3 to W20, even if the deterioration of healing in the VAG at W28 was caused by a patient with a wound that reopened

Figure 6 is the Kaplan-Meyer plot reporting the rate (number) of patients with completely healed wounds (100%).

In fact, the VAG showed progressive healing, whereas the CG showed a high degree of healing around week 20. At this time, wounds still not com-pletely healed were present in about 30% of VAG (only 10% with an area larger than 1 cm2) patients and 25% of CG (all with an area larger than 1 cm2). However, these small differences between the two groups were statistically significant (P=0.621, Log Rank Test for equality of healing distributions for group).

Discussion

The aim of this study was to investigate the effects of using a prosthesis based on VASS in a sample of patients with dysvascular TT amputa-tion and open residual limb wounds. Our results showed that amputees fitted with VASS use the prosthesis for a longer period of time per week as compared to amputees fitted with a standard passive suction socket system. This finding is fur-ther supported by a higher mobility in the VAG as reflected by higher LCI scores. Moreover VASS allowed for earlier prosthesis fitting and faster rehabilitation of walking capabilities. This may also have been encouraged by our study proto-col in which the conventional group was not al-lowed to start using the prosthesis and undergo training before almost complete wound healing. This may explain why the results in the VASS group are better at the end of rehabilitation pro-gram. On the other hand it is a common clinical practice to authorize the use of a standard SS only when the stump is healed. This conserva-

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TRABALLESI RESIDUAL LIMB WOUNDS OR ULCERS HEAL IN TRANSTIBIAL AMPUTEES

622 EUROPEAN JOURNAL OF PHYSICAL AND REHABILITATION MEDICINE December 2012

References

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2. Taylor SM, Kalbaugh CA, Blackhurst DW, Hamontree SE, Cull DL, Messich HS et al. Preoperative clinical factors predict post-operative functional outcomes after major lower limb ampu-tation: an analysis of 553 consecutive patients. J Vasc Surg 2005;42:227-35.

3. Ebskov BL. Dysvascular amputations and long-term survival in a 20-year follow-up study. Int J Rehab Res 2006;29:325-8.

4. Tentolouris N, Al-Sabbagh S, Walker MG, Boulton AJ, Jude EB. Mortality in diabetic and nondiabetic patients after amputations performed from 1990 to 1995: a 5-year follow-up study. Diabe-Diabe-tes Care 2004;27:1598-604.

5. Raya MA, Gailey RS, Fiebert IM, Roach KE. Amputation impair-Raya MA, Gailey RS, Fiebert IM, Roach KE. Amputation impair-Amputation impair-ment variables predicting activity limitation in individuals with lower limb. Prosthet Orthot Int 2010;34:73-83.

6. Dudek NL, Marks MB, Marshall SC, Chardon JP. Dermatologic conditions associated with use of a lower extremity prosthesis. Arch Phys Med Rehabil 2005;86:659-63.

7. Levy SW. Wound care: skin care determines prosthetic comfort. BioMechanics 1999;Apr:45-54.

8. Meulenbelt HE, Geertzen JH, Jonkman MF, Dijkstra PU. De-terminants of skin problems of the stump in lower-limb am-putees. Arch Phys Med Rehabil 2009;90:74-81.

9. Traballesi M, Porcacchia P, Averna T, Angioni C, Lubich S, Di Meo F, Brunelli S. Prognostic factors in prosthetic reha-bilitation of bilateral dysvascular above-knee amputee: is the stump condition an influencing factor? Eur Medicophys 2007;43:1-6.

10. Maki BE, Holliday PJ, Topper AK. Fear of falling and postural performance in the elderly. J Gerontol 1991;46:M123-31.

11. Myers A, Gonda G. Research on physical activity in the eld-erly: practical implications for program planning. Can J Aging 1991;5:175-87.

12. Traballesi M, Averna T, Delussu AS, Brunelli S. Trans-tibial prosthesization in large area of residual limb wound: is it pos-sible? A case report. Disabil Rehabil Assist Technol. 2009;4:373-5.

13. Levy SW. Skin problems of the amputee. St Luis, MO: Warren H Green; 1983.

14. van Velzen AD, Nederhand MJ, Emmelot CH, Ijzerman MJ. Early treatment of trans-tibial amputees: retrospective analy-sis of early fitting and elastic bandaging. Prosthet Orthot Int 2005;29:3-12.

15. Chan KM, Tan ES. Use of lower limb prosthesis among elderly amputees. Ann Acad Med Singapore 1990;19:811-6.

16. Meulenbelt HE and Geertzen JHB. Comment on Salawu et al., Prosthet Orthot Int 2007;31:207-8.

17. Berke G. Postoperative management of the lower extremity amputee-standards of care. Official findings of the Consensus conference. J Prosthet Orthot 2004;16:6-12.

18. VanRoss ER, Johnson S, Abbott CA. Effects of early mobiliza-tion on unhealed dysvascular trans-tibial amputation stumps: a clinical trial. Arch Phys Med Rehabil 2009;90:610-7.

19. Salawu A, Middleton C, Gilbertson A, Kodavali K, Neumann V. Stump ulcers and continued prosthetic limb use. Prosthet Orthot Int 2006;30:279-85.

20. Beil TL, Street GM, Covey SJ. Interface pressures during ambu-lation using suction and vacuum-assisted prosthetic sockets. J Rehabil Res Dev 2002;39:693-700.

21. Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet 2005;366:1704-10.

22. Bui KM, Raugi GJ, Nguyen V�, Reiber GE. Skin problems in in-Bui KM, Raugi GJ, Nguyen V�, Reiber GE. Skin problems in in-Skin problems in in-

the efficacy for using the VASS as a definitive pros-thesis even in the case of unhealed stumps: similarly, we found that wound healing (wound area smaller than 1 cm2) occurred in 90% of the VAG patients within 20 weeks. Moreover the early mobilization proposed by VanRoss needs the fabrication of two devices (PPAM aid and, later, a standard TT socket) while we found that a single VASS was sufficient to obtain similar results.

Despite of the above-mentioned advantages of using VASS, we found a problem related to the pro-cedure involved in donning the liner, socket and sleeve. In fact, attention and skills are needed to carry out these procedures correctly. The older pa-tients sometimes failed to correctly carry out one or more of those procedures, compromising the vac-uum system and its suspension strength. If some air remained between the skin of the residual limb and the liner, it did not preclude prosthetic use but caused a blister as noted at W6 and W28 in a VAG user (Figure 5). It is worth to note that as the vacuum is produced by a mechanical pump the strength and stability of the vacuum depends on the activity of the patient. The more active the pa-tient is the stronger and more stable is the vacuum between the socket and the liner. It is conceivable that in young and more active patients the effect of the vacuum may be higher. Nevertheless, we ob-served satisfactory results in terms of prosthetic use in VAG.

The main limitation of this study is the small sam-ple size, also considering that three patients dropped out of the CG. Another limitation is the lack of a group of subjects fitted early with a prosthesis based on the standard SS system. In fact, our study de-sign encouraged the early use of a VASS prosthesis whereas the control group was treated according to common clinical practice, being not allowed to start using the prosthesis and hence the training early. These limitations should be considered in future re-search. Future studies should enrol bigger patient samples, investigate if early use of a standard suc-tion socket is possible in patients with open residual limb wounds, and, if so, compare early VAG use to early SS use.

In conclusion, when open residual limb wounds are present, use of a prosthesis with VASS may be effective for early ambulation recovery with no substantial pain and no inhibition of wound heal-ing.

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quantifying components of high-definition images. Version 1.2.2. [cited 2012 April 24]. Available at: http://www.jmicrovision.com

30. Board WJ, Street GM, Caspers C. A comparison of trans-tibial amputee suction and vacuum socket conditions. Prosthet Or-thot Int 2001;25:202-9.

Preliminary data were presented at the 13th World Congress of the International Society for Prosthetics and Orthotics (ISPO), Leipzig, Germany, 2010: Brunelli S, Delussu A S, Averna T, Pellegrini R, “First Statistical Evidences about the Differences between the Use of an Assisted or Passive Vacuum Socket System in Unhealed Stumps of TT Amputees”. Congress Lecture (3116) Abstract (314): 660-661.

Funding.—This study was supported by a grant from Otto Bock HealthCare, Duderstadt, Germany.

Conflicts of interest.-None.

Received on September 19, 2011.Accepted for publication on December 21, 2011.Epub ahead of print on May 28, 2012.

dividuals with lower-limb loss: Literature review and proposed classification system. J Rehabil Res Dev 2009;46:1085-90.

23. Functional Levels and Lower Extremity Prostheses (K-Levels) - Region B Medicare Supplier Bulletin. DMEPOS bulletin 95-01, January 1995.

24. Casale R, Alaa L, Mallick M, Ring H. Phantom limb related phe-nomena and their rehabilitation after lower limb amputation. Eur J Phys Rehabil Med 2009;45:559-66.

25. Fergason J, Smith DG. Socket considerations for the patient with a transtibial amputation. Clin Orth Rel Res 1999;361:76-84.

26. Gauthier-Gagnon C, Grise MC, Lepage Y. The Locomotor Capabil-ity Index: content validity. J Rehabil Outcomes Meas 1998;2:40-6.

27. Ferriero G, Dughi D, Orlandini D, Moscato T, Nicita D, Franchi-gnoni F. Measuring long-term outcome in people with lower limb amputation: cross-validation of the Italian versions of the Prosthetic Profile of the Amputee and Prosthesis Evaluation �uestionnaire. Europa Medicophys 2005;41:1-6.

28. Huskisson EC. Measurement of pain. Lancet 1974;2:1127-31.29. Roduit, N. JMicroVision: Image analysis toolbox for measuring and

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