Residual limb wounds or ulcers heal in transtibial amputees using an active suction socket system. A randomized controlled study

Background: The factors that determine successful rehabilitation after lower limb amputation have been widely investigated in the literature, but little attention has been paid to the type of prosthesis and clinical state of the residual limb, particularly the presence of open ulcers. Aim: The aim of this study was to investigate the effects of a vacuum-assisted socket system (VASS) in a sample of trans-tibial amputees with wounds or ulcers 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 program, all VASS users were able to walk independently with their prosthesis as reflected by a median Locomotor 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 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 significantly differ between the two groups. Conclusion: These results showed that the VASS prosthesis allowed early fitting with prompt ambulation recovery without inhibiting wound healing or increasing pain.