Limb Health and Socket Pressure in Response to Powered Ankle Protheses

NCT05112679 | Completed Results DMC FDA Device

• 1 other identifier: 12350
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pressure Ulcer, Ankle; Prosthesis User; Prosthesis Durability; Mobility Limitation; Skin Wound; Amputation; Traumatic, Foot; Amputation; Limb Deficiencies

Outcome Measures

Primary Outcomes (1)

• Powered Transtibial Prosthesis on Socket Pressure

  effects of a powered transtibial prosthesis on the socket pressure for level-ground walking to a microprocessor-controlled prosthesis and a passive prosthesis

  4 weeks

Secondary Outcomes (2)

• Change in Skin Perfusion

  4 weeks

• Transepidermal Water Loss (TEWL)

  4 weeks

Study Arms (2)

Proprio Foot

EXPERIMENTAL

each participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio

Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock

Empower foot

EXPERIMENTAL

ach participant was randomized to use Proprio or empower based on randomization followed by switching the other empower or proprio

Device: PROPRIO FOOT® by Ossur & Empower ankle by Ottobock

Interventions

PROPRIO FOOT® by Ossur & Empower ankle by Ottobock DEVICE

PROPRIO FOOT is a microprocessor controlled foot that offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation, Empower: Empower powered ankle offer great potential to more completely restore the locomotor capabilities of individuals with transtibial amputation.

Empower foot; Proprio Foot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• University of Notre Dame: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46228, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Prosthesis Failure; Mobility Limitation

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Sashwati Roy, PI
• Organization: University of Pittsburgh

sar453@pitt.edu

412 6240422

Study Officials

• Sashwati Roy, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: November 9, 2021
• Study Start: November 15, 2021
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: November 25, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: 6 months after completion
• Access Criteria: Email study contact

Locations

US (1)