Adherence and Perspiration While Wearing Lower Limb Prostheses

NCT03900845 | Completed Results DMC FDA Device

• 2 other identifiers: W81XWH-18-1-0559CDMRP-OR170314
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses. It doesn't take long before the presence of sweat on the residual limb leads to a lack of confidence in the security of their prosthetic suspension. Some circumstances allow the wearer to doff the prosthesis before it falls off, wipe it and the residual limb dry, and then don it again. Another option is to simply reduce the intensity of activities before sweat becomes a problem. However, the Warfighter amputee may not be afforded such accommodations. For these service personnel, inadequate moisture management can significantly limit or inhibit their mobility. The objective of the proposed research is to provide lower limb amputees who work in demanding environments with a prosthesis that remains secure despite profuse residual limb sweating without compromising residual limb health and comfort. The aim of this research is to compare three different, lower limb prosthetic suspension systems and identify which is most effective at maintaining a secure adherence when worn in conditions that result in profuse sweating. The investigators also aim to compare how the three study prostheses effect residual limb skin health and comfort when participants pursue their usual activities in the home, work, and community environments. To achieve these aims, the investigators will to recruit 25 below-knee amputees. Each subject will be asked to be asked to wear: (1) their as-prescribed prosthesis, (2) a prosthesis with a perforated elastomeric liner that allows sweat to flow away from the skin, and (3) a prosthesis that has a battery and body-weight activated pump to flow air between the prosthesis and the residual limb skin, allowing expulsion of any accumulated sweat. Subjects will wear each of these prostheses in the home, work, and community environments for two weeks, after which the investigators will measure their residual limb health and comfort. Subjects will then walk on a treadmill in a room whose climate will be set to Middle East-like conditions: 35 °C (95 °F) and 50% relative humidity. After 30 minutes, the investigators will measure any slippage of their prosthesis relative to their limb and how much sweat is expelled. The investigators hypothesize there will be differences in the amount of slippage, residual limb health, and comfort between the three prostheses.

Conditions

Lower Extremity Amputation

Keywords

lower limb prosthesis; transtibial amputation; below knee amputation; adherence; perspiration

Outcome Measures

Primary Outcomes (2)

• Adherence

  The amount of slippage (loss of adherence) will be determined by measuring the distance between a mark on the skin and the proximal border of the liner. Adherence will be measured in millimeters.

  After the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.

• Expelled Perspiration

  The amount of expelled perspiration will be determined by tare weight. Expelled perspiration will be measured in grams.

  After the 90-minute rest-walk-rest protocol where subjects enter our environmental chamber for a 30-minute seated acclimation and a 30-minute treadmill walk and then exit the chamber for a 30-minute seated rest.

Secondary Outcomes (3)

• Skin Hydration

  After wearing the study prosthesis in the home, work, and community environments for two weeks

• Transepidermal Water Loss

  After wearing the study prosthesis in the home, work, and community environments for two weeks

• Satisfaction With the Prosthesis

  After wearing the study prosthesis in the home, work, and community environments for two weeks

Study Arms (2)

Environmental Chamber

EXPERIMENTAL

All participants will wear all three study prostheses in an environmental chamber set at 35 degrees Celsius and 50% relative humidity.

Device: Dynamic Air Exchange - Rising Edge Design (DAE-RED); Device: Perforated elastomeric liner; Device: As-prescribed prosthesis

Field Measurements

EXPERIMENTAL

All participants will wear all three study prostheses in their home, work, and community environments for two weeks.

Device: Dynamic Air Exchange - Rising Edge Design (DAE-RED); Device: Perforated elastomeric liner; Device: As-prescribed prosthesis

Interventions

Dynamic Air Exchange - Rising Edge Design (DAE-RED) DEVICE

The DAE-RED suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump. To use the DAE-RED, subjects will be fit with a modified patellar tendon-bearing socket that fits over a custom liner and sock. Up to four air intake ports are located proximally on the liner, approximately 25 mm superior to the socket brim. These ports incorporate a microvalve that allows air to flow into the liner-skin interstitial space while still maintaining a vacuum suspension. Distally, the pin lock has a 3-mm hole along its longitudinal axis that allows perspiration to be expelled into a distal reservoir. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot with Unity pump and foot cover.

Environmental Chamber; Field Measurements

Perforated elastomeric liner DEVICE

The unique element of this perforated elastomeric liner are small perforations (\~0.3 mm diameter), uniformly distributed on a 4 x 5 mm grid, but with no perforations on the distal umbrella, that allow perspiration to be exuded into the liner-socket interstitial space. To use the perforated elastomeric liner, subjects will be fit with a modified patellar tendon-bearing socket that fits over a sock and the perforated elastomeric liner with a pin lock. The sock, worn between the socket and the liner, is used to absorb perspiration that is transported through the perforations in the liner. When needed for residual limb volume control, additional socks will be donned and included in tare weighing. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot and cosmesis.

Also known as: Uniprox Softskin Air prosthesis liner

Environmental Chamber; Field Measurements

As-prescribed prosthesis DEVICE

The individual's as-prescribed suspension system is the prosthesis prescription that the patient and their clinical care team believes is the best prosthesis for their needs.

Environmental Chamber; Field Measurements

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transtibial amputation
• Been fit with a prosthesis and used it for at least six months
• Wear the prosthesis for four or more ours on an average day
• Ambulate without upper extremity aids
• Able to walk for 30 minutes on a treadmill

You may not qualify if:

• Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources (determined at initial visit)
• Current skin irritation or injury on residual limb
• Osteoarthritis, injury, or pain that interferes with walking ability
• Currently incarcerated
• Pregnant (determined via self-report)
• Inadequate cognitive function or language proficiency to consent to participate
• High (\>20%) coronary heart disease risk at 10 years as determined by heir Framingham Risk Score

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• United States Department of Defense: collaborator

Study Sites (1)

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, 98108, United States

Location

Results Point of Contact

• Title: Glenn K Klute, PhD
• Organization: Seattle Institute for Biomedical and Clinical Research

Glenn.Klute@va.gov

2062776792

Study Officials

• Glenn K Klute, PhD

  Dept. of Veterans Affairs

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will use a within-subject crossover design to identify differences in adherence (slippage), expulsion of perspiration, residual limb health, and comfort that may exist between the three study prostheses. The three study prostheses include: (1) a perforated elastomeric liner intended to transport perspiration away from the residual limb, (2) a dynamic air exchange - rising edge design (DAE-RED) suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump that expels perspiration into a distal chamber, and (3) the participant's as-prescribed prosthesis. The order in which participants wear the perforated elastomeric liner and the DAE-RED systems will be randomized (first or third), but the as-prescribed prosthesis will always be worn second.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 3, 2019
• Study Start: February 17, 2019
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: January 27, 2026
• Results First Posted: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within six months after publication of final study findings.
• Access Criteria: Open access through Pubmed Central, SimTk, PhysioNet, or other similar open-source data repository websites. The investigators will work with manuscript publishers when possible to link the final study data sets to an appendix or supplemental materials on the publisher websites.

Locations

US (1)