Moisture Management Liner At-Home Evaluation

Amputation Clinical Trial

Official title:

Moisture Management Liner At-Home Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05124873
• Other study ID #: E00572.2a
• Secondary ID: 2020/09/1E00572.
• Status: Completed
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: September 27, 2022

Study information

• Verified date: February 2024
• Source: Liberating Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by nonbreathable and non-thermally conductive materials that can create a warm and ultimately moist environment.

The investigators have developed a silicone liner approach to passively conduct heat from the skin using thermally conductive elastomers. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.

Description:

The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by nonbreathable and non-thermally conductive materials that can create a warm and ultimately moist environment. These layers consist of a prosthetic liner that rolls onto the limb and traps heat and occasional extra prosthetic socks. Studies found increases in socket temperature after the prosthesis was donned. Temperatures were found to remain elevated long after activity cessation and even a rest period of double the duration of the preceding activity period is insufficient to return the limb to its initial temperature. A small amount of activity can cause the socket temperature to elevate and remain at an uncomfortable level for an extended period of time, which can lead to decreased wear times. In summary, an uncomfortable socket/residual limb interface decreases prosthesis use among amputees who want to remain active in their lives.

The investigators have developed a silicone liner approach to passively conduct heat from the skin using thermally conductive elastomers. A technology that can provide thermal control while retaining adequate suspension, weight, and other prosthetic characteristics would benefit many prosthesis wearers.

This study will focus on investigating the efficacy of this novel moisture and thermal management (experimental) liner.

The rationale for this study is to determine how well the new technology can regulate the residual limb temperature and reduce the moisture generation in a home environment where the device would ultimately be utilized.

The primary objective of this study is to measure the effects of residual limb moisture and thermal management on quality of life (QoL) and functional outcomes. Reducing temperature increases of the residual limb inside the prosthetic socket would result in less sweating and greater comfort while wearing the prosthesis, and ultimately greater function and better quality of life as measured by standard functional and QoL outcome measures.

A prospective design will be implemented for this study. Research participants will be consented by LTI over the phone. Residual limb measurements will be received from the participant to confirm liner sizing. One 'experimental' prototype liner will be created for each participant. Subjects with a similar liner size and profile to the available experimental liners will be targeted. Temperature and step-count sensors will be placed on the participant's prosthesis to log daily measurements. Testing will consist of 2 site visits, with the entire study lasting approximately 5 weeks.

Lower limb prosthesis users will be recruited for the study and consented with an approved protocol. Research participants will represent a convenience sample and will reflect the local population of people with lower limb differences who use prosthetic sockets and could benefit from temperature control within the socket.

A maximum of 16 subjects will be recruited for this study. This sample size accounts for subject drop out and other losses (such as incomplete log data, etc.) to yield usable data from the target 12 subjects required by the power analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Lower limb amputee

• Be willing and able to complete the tasks outlined

• Are at least 6 months on a lower-limb prosthesis

• Fits within an experimental liner (cushion style liner and size 23.5-28 cm)

• Can understand English in order to be properly consented and provide their feedback to the study personnel

Exclusion Criteria:

• The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study

• Other unforeseen disqualifying criteria (such as specific cognitive issues, etc.)

Related Conditions & MeSH terms

• Amputation
• Amputation Stump
• Amputees
• Congenital Abnormalities
• Lower Limb Deformity
• Prosthesis
• Prosthesis User

Intervention

Device:
• Moisture Management Liner
A prototype liner designed to reduce heat that builds up on the limb.

Locations

Country	Name	City	State
United States	Liberating Technologies, Inc.	Holliston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Liberating Technologies, Inc.	Vivonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Dermatology Life Quality Index (mDLQI)	The Dermatology Life Quality Index is a simple questionnaire designed to measure the health-related quality of life of adult patients suffering from various skin diseases. A modified version of the questionnaire was created to be more directly applicable to persons with amputation. The modified survey can have a score from 0 to 27, with lower numbers indicating a better outcome. Scores on the unmodified DLQI of 0-1 indicate no affect at all from a skin condition on a patient's life. Score ranges of 2-5, 6-10, 11-20 and 21-30 are considered to have 'small,' 'moderate,' 'very large,' and 'extremely large' effects on a patient's life, respectively.	4 weeks
Secondary	User Satisfaction User Satisfaction User Satisfaction	Surveys regarding user satisfaction while wearing and walking in the liner. A custom questionnaire using a 5 point Likert scale (1-5) will be used to rate different aspects of the experimental liner. Such as comfort (higher value is equal to a better outcome) and how much the participant perceives they sweat in the liner (lower value is equal to a better outcome).	4 weeks
Secondary	Dermatology Life Quality Index (DLQI)	The Dermatology Life Quality Index (DLQI) is a simple, self-administered and user-friendly validated questionnaire.; The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease.	1 week
Secondary	EuroQol-5D	The EuroQol visual analogue scale (VAS) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	4 weels
Secondary	Prosthesis Evaluation Questionnaire - Residual Limb Health Scale	The Prosthesis Evaluation Questionnaire (PEQ) is a set of scales to describe the function of a lower limb prosthesis and the prosthesis-related quality of life of a person with an amputation. For this study only the Residual Limb Health Scale was used as it most closely related to the skin health problems that could be related to the heat and sweat generated in a prosthetic liner.; The questions use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line to the point at which the respondent's mark crosses the line. Each line is 100 mm long and is always measured from the left (0-100). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response.	4 weeks