Terminated due to lack of enrollment

We expect subjects in the interventional groups, who wear shrinkers, to heal more quickly than control subjects who wear no shrinkers. We also expect them to experience greater reduction in residual limb volume during the early stages of postoperative care leading up to prosthetic fitting, fewer healing complications, reduced time to the prosthetic fitting, increased time to the first prosthetic socket replacement, and fewer socket replacements by the end of the "transition to stable phase".

Edema is an inevitable result of amputation surgery. Persistent edema can affect oxygen and nutrient flow into, as well as waste flow out of the residual limb. Shrinkers are a common and effective treatment for edema. However, their influence on healing and long term limb volume has not been studied. This study will pertain to human subjects affected by primary transtibial amputation. Two interventional groups of patients will use shrinkers with different levels of compression as part of their rehabilitation. A third, control group will not use shrinkers. The groups will be studied to determine the effects of shrinker use on healing and long term residual limb volume.

Inclusion Criteria:

• Recently undergone primary transtibial amputation
• Patients between ages of 18 and 100 years of age

Exclusion Criteria:

• Undergone previous amputations above the Symes level

Early termination of the study due to poor enrollment numbers, i.e., only 4 subjects were enrolled. No analysis was performed due to insufficient data to assess outcome measures. The number of patients in each group is unknown.

All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed due to early termination.

Early termination of the study due to poor enrollment numbers, (only 4 subjects were enrolled). No analysis was performed due to insufficient data to assess outcome measures.