Transtibial Amputation
Conditions
Keywords
volume, healing, shrinker, transtibial amputation, individuals who have undergone transtibial amputation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEcompression shrinker
Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Time to Healing | 1 year | time to healing in each group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Shrinker Patients receive 20-30 mmHg or 30-40 mmHg shrinker, an elastic compression garment that is worn on the residual limb and is used to reduce edema and promote healing.
compression shrinker: Two levels of compression: 20-30 mmHg or 30-40 mmHg shrinker | 0 |
| No Shrinker Patients will receive no shrinker | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | Total | — |
|---|---|---|
| Age, Categorical <=18 years | 0 | — |
| Age, Categorical >=65 years | 0 | — |
| Age, Categorical Between 18 and 65 years | 0 | — |
| Region of Enrollment United States | — | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Reduction in Time to Healing
time to healing in each group
Time frame: 1 year
Population: study was closed due to low enrollment. Data were not collected.