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Limb Health and Socket Pressure in Response to Powered Ankle Protheses
NA trial testing PROPRIO FOOT® by Ossur & Empower ankle by Ottobock in Pressure Ulcer, Ankle in 6 participants. Completed in 19 July 2023.
| Lead sponsor | Indiana University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 6 |
| Start date | 15 November 2021 |
| Primary completion | 19 July 2023 |
| Estimated completion | 19 July 2023 |
| Sites | 1 location across United States |
Indiana University
18 and older, any sex, with Pressure Ulcer, Ankle or Prosthesis User. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis
| Group | Value | 95% CI |
|---|---|---|
| Proprio Foot | 0.58 | ± 0.01 |
| Empower Ankle | 0.25 | ± 0.03 |
Changes measured with laser speckle imaging. The perfusion data is expressed as perfusion units (PU) which is a dimensionless ratio calculated by dividing the standard deviation of the intensity in a given area by the mean intensity within that area, essentially representing the degree of variation in the speckle pattern. Higher number indicates greater perfusion which is better outcome.
| Group | Value | 95% CI |
|---|---|---|
| Proprio Foot | 1.1 | ± 0.75 |
| Empower Ankle | 0.8 | ± 0.7 |
Water loss change is measured via the TEWL device- the lower score mean a better outcome for TEWL.
| Group | Value | 95% CI |
|---|---|---|
| Proprio Foot | 2.0 | ± 0.61 |
| Empower Ankle | 0.8 | ± 0.21 |
this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05112679.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing