N/A
Completed N=6
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
Pressure Ulcer, Ankle · Prosthesis User · Prosthesis Durability · Mobility Limitation
Source: ClinicalTrials.gov NCT05112679 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Powered Transtibial Prosthesis on Socket Pressure — 0.58; 0.25 kPa/kg — p=0.009
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Powered Transtibial Prosthesis on Socket Pressure |
0.58; 0.25 | 0.009 sig |
| SECONDARY Change in Skin Perfusion |
1.1; 0.8 | — |
| SECONDARY Transepidermal Water Loss (TEWL) |
2.0; 0.8 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 18 and above
- Weight ≤ 280 lb
- Ambulate at a K3 level or higher-level determined from patient EHR
- At least 3 months post-amputation per physician discretion
- Residual limb length greater than 4.5 inches
- Use of a passive prosthesis
- Unilateral transtibial amputees
- Must be able to ambulate without any assistive devices
- Subjects must be able to follow directions and give informed consent on their own
Exclusion Criteria
- Conditions and/or co-morbidities that would prevent wearing a prosthetic socket, affect gait, or influence function of the contralateral limb
- Other amputees
- Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
- Women who are pregnant or who plan to become pregnant in the near future
- Individuals diagnosed with renal failure
- Participants unwilling to wear a cloth face covering for the duration of each visit
Data sourced from ClinicalTrials.gov (NCT05112679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.