N/A N=6 Randomized Supportive Care

Limb Health and Socket Pressure in Response to Powered Ankle Protheses

Pressure Ulcer, Ankle · Prosthesis User · Prosthesis Durability · Mobility Limitation · Skin Wound

Bottom Line

View on ClinicalTrials.gov: NCT05112679 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2025

Primary outcome: Primary: Powered Transtibial Prosthesis on Socket Pressure — 0.58; 0.25 kPa/kg — p=0.009

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Jul 2023

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	—

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.

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

View full record on ClinicalTrials.gov →

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.