Effects of Temperature Control Liner Materials on Long-Term Outcomes of Prothesis Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03428815
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : April 4, 2018
Widener University
Information provided by (Responsible Party):
Goeran Fiedler, University of Pittsburgh

Brief Summary:
This clinical trial will compare how many days per year people with lower limb prosthesis do not wear their prosthesis when fitted with a conventional liner and a liner made with phase change materials.

Condition or disease Intervention/treatment Phase
Artificial Limbs Skin Diseases Device: Prosthesis suspension liner Not Applicable

Detailed Description:

Background: The proposed work will generate evidence-based practice guidance for temperature control liner technologies and allow providers to optimize care to Service members and Veterans with limb loss. Sizeable numbers of Service members and Veterans live with limb loss, mostly due to traumatic musculoskeletal injury. Addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from accidental falls. Any of those occurrences can render the prosthesis temporarily useless, making it challenging for users to engage in many activities of daily life, including work, exercise, and social participation. Many of the described issues originate at the interface between residual limb and prosthetic socket, where the objectives of sufficient weight distribution and suspension are conflicting with the necessity to facilitate heat exchange and limit contact pressure and friction.

Recently, prosthesis liners that contain phase-change material have become commercially available, holding the promise that the micro climate at the interface between the residual limb skin and the prosthetic socket can be regulated to reduce the users' tendency to sweat. Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners. However, the clinical relevance of those findings remains unclear. While (perceived) socket comfort is certainly an important criterion in prosthesis fitting, it may be claimed that only tangible functional benefits are of concern.

Objective/Hypothesis: The purpose of this study is to investigate whether longer (6+ months) periods of use of phase-change material based temperature control liners have clinically meaningful effects.

It is hypothesized that use of phase-change material infused liners will improve prosthesis utilization (measured in days of prostheses use per time), physical performance (measured by 2-minute walk test), and self-reported prosthesis related quality of life (assessed by questionnaire). The research follows the rationale that lower and steadier skin temperatures should result in reduced sweat, friction, skin damage, and prosthesis abandonment. This would encourage users to wear their prosthesis for longer periods of time and for an expanded array of purposes, thus increasing their ability to ambulate and to engage in a greater variety of activities.

Specific Aims:

  1. To compare phase-change material liners to conventional liners with regard to activity and participation
  2. To quantify the effect of phase-change material liners on prosthesis related quality of life and physical performance over time
  3. To investigate the relationship between perceived benefits of phase-change material liners and patient-centric outcomes

Study Design: The proposed study will utilize a double-blind longitudinal cross-over research design. A sample of trans-tibial prosthesis users will be wearing their regular gel or silicone liners for six months and phase-change material liners for another six months in a randomized sequence. Their prostheses will be equipped with activity monitors, and participants will be asked to maintain a record of days when they could not wear their prosthesis due to any perceived issues with their residual limb or socket fit. In 1.5-month intervals, subjects' activity, physical performance, and overall prosthesis assessment will be recorded using standardized methods.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Temperature Control Liner Materials on Long-Term Outcomes of Prothesis Use
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Arm Intervention/treatment
Experimental: PCM liner
Willowwood Smart Temp Liner
Device: Prosthesis suspension liner
Liners out of phase change material will be fitted

Active Comparator: regular liner
User's regular prescribed liner
Device: Prosthesis suspension liner
Liners out of phase change material will be fitted

Primary Outcome Measures :
  1. Days without prosthesis [ Time Frame: 6 months ]
    Days with less than 10% of prosthesis steps than average

Secondary Outcome Measures :
  1. Daily step count [ Time Frame: 6 months ]
    Measured by prosthesis-attached step counter

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • use of a prosthesis with liner suspension,
  • at least one year of prosthesis use,
  • a well-fitting socket,
  • a matured residual limb (stable limb volume) that has not required socket modifications in the previous year,
  • the ability to walk with the prosthesis outdoors without notable limitations (K-Level 3),
  • stable weight,
  • absence of acute medical conditions that would temporarily affect the ability to use prostheses.

Exclusion Criteria:

  • use of a non-standard liner size,
  • current use of a PCM liner as the regular suspension system,
  • known allergies against liner materials,
  • any inability to understand the protocol and to comply with the associated tasks, such as maintaining a log of days when the prosthesis could not be used.
  • anticipated provision of a new prosthesis or extended (longer than one month) absences from the region during the study period

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 identifier (NCT number): NCT03428815

Contact: Goeran Fiedler, PhD 4126246475

United States, Pennsylvania
Bakery Square MSPO labs Recruiting
Pittsburgh, Pennsylvania, United States, 15206
Contact: Goeran Fiedler, PhD   
Principal Investigator: Goeran Fiedler, PhD         
Sponsors and Collaborators
Goeran Fiedler
Widener University

Responsible Party: Goeran Fiedler, Assistant Professor, University of Pittsburgh Identifier: NCT03428815     History of Changes
Other Study ID Numbers: PRO17090574
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified data may be shared in the future

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Skin Diseases