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Adherence and Perspiration While Wearing Lower Limb Prostheses

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ClinicalTrials.gov Identifier: NCT03900845
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : November 3, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Glenn Klute, Seattle Institute for Biomedical and Clinical Research

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.


Condition or disease Intervention/treatment Phase
Lower Extremity Amputation Device: Dynamic Air Exchange - Rising Edge Design (DAE-RED) Device: Perforated elastomeric liner Device: As-prescribed prosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Novel Lower-Limb Prostheses: Comparing Adherence, Perspiration, and Residual Limb Skin Health in a Hot, Humid Environment and During Activities of Daily Living
Actual Study Start Date : February 17, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Environmental Chamber
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)
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.

Device: Perforated elastomeric liner
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.
Other Name: Uniprox Softskin Air prosthesis liner

Device: As-prescribed prosthesis
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.

Experimental: Field Measurements
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)
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.

Device: Perforated elastomeric liner
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.
Other Name: Uniprox Softskin Air prosthesis liner

Device: As-prescribed prosthesis
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.




Primary Outcome Measures :
  1. Adherence [ Time Frame: 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. ]
    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.

  2. Expelled Perspiration [ Time Frame: 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. ]
    The amount of expelled perspiration will be determined by tare weight. Expelled perspiration will be measured in grams.


Secondary Outcome Measures :
  1. Skin hydration [ Time Frame: After wearing the study prosthesis in the home, work, and community environments for two weeks ]
    Skin hydration will be measured with a specialized instrument (Corneometer). A probe, acting as a capacitor, will apply an electric field to penetrate the skin (i.e., epidermis stratum corneum) on the posterior compartment of the residual limb to a depth of 10 to 20 μm. The amount of electrical charge stored by the capacitor is a function of skin hydration. Greater water content is proportional to higher capacitance, which is converted to converted to arbitrary units from 0 to 99.

  2. Transepidermal water loss [ Time Frame: After wearing the study prosthesis in the home, work, and community environments for two weeks ]
    Transepidermal water loss will be measured with a specialized instrument (Tewameter). A hollow cylinder probe with two pairs of sensors (temperature and relative humidity) will measure the density gradient of the water evaporation on the posterior compartment of the residual limb in units of g/m2/h.

  3. Satisfaction with the prosthesis: 11-point Likert scale [ Time Frame: After wearing the study prosthesis in the home, work, and community environments for two weeks ]
    An 11-point Likert scale will be used to record the subject's perception of satisfaction with the study prostheses. Participants will be asked to rate their satisfaction with the prosthesis on a 0 - 10 scale where 0 and 10 represent the least amount of satisfaction and the most amount of satisfaction imaginable, respectively.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900845


Contacts
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Contact: Rebecca Walker 206.204.6186 Rebecca@sibcr.org
Contact: Leila Kirkpatrick 206.764.2991 Leila.Kirkpatrick@va.gov

Locations
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United States, Washington
VA Puget Sound Health Care System Seattle Division Recruiting
Seattle, Washington, United States, 98108
Contact: Rebecca Walker    206-204-6186    Rebecca@sibcr.org   
Contact: Leila Kirkpatrick    206.764.2991    Leila.Kirkpatrick@va.gov   
Principal Investigator: Glenn K Klute, PhD         
Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
United States Department of Defense
Investigators
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Principal Investigator: Glenn K Klute, PhD Dept. of Veterans Affairs
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Responsible Party: Glenn Klute, Principal Investigator, Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT03900845    
Other Study ID Numbers: W81XWH-18-1-0559
CDMRP-OR170314 ( Other Grant/Funding Number: Department of Defense )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified, anonymized dataset in machine-readable format will be created and shared for all individual participant data (IPD) that underlie results in a publication. The investigators will follow 164.514(a) of the HIPAA Privacy Rule for de-identification of IPD.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenn Klute, Seattle Institute for Biomedical and Clinical Research:
lower limb prosthesis
transtibial amputation
below knee amputation
adherence
perspiration