Trial Outcomes & Findings for Moisture Management Liner At-Home Evaluation (NCT NCT05124873)

Results Overview

The modified Dermatology Life Quality Index (mDLQI) is a modified version of the Dermatology Life Quality Index (DLQI). The DLQI 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 (mDLQI) was developed to be more directly applicable to persons with amputation (i.e., revised wording to apply to the skin on their residual limb). The modified survey is scored from 0 to 27, with lower numbers indicating a better outcome.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-06-17

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Prosthetic Liner Moisture Management Liner: A prototype liner designed to reduce heat that builds up on the limb. The participant wears this liner at home for about 4 weeks and provides feedback on the prototype.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Prosthetic Liner n=1 Participants Moisture Management Liner: A prototype liner designed to reduce heat that builds up on the limb.
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants
Region of Enrollment United States	1 participants n=1 Participants
Modified Dermatology Life Quality Index (mDLQI)	5 units on a scale n=1 Participants

PRIMARY outcome

Timeframe: 4 weeks

The modified Dermatology Life Quality Index (mDLQI) is a modified version of the Dermatology Life Quality Index (DLQI). The DLQI 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 (mDLQI) was developed to be more directly applicable to persons with amputation (i.e., revised wording to apply to the skin on their residual limb). The modified survey is scored from 0 to 27, with lower numbers indicating a better outcome.

Outcome measures

Outcome measures
Measure	Experimental Prosthetic Liner n=1 Participants Moisture Management Liner: A prototype liner designed to reduce heat that builds up on the limb. The participant wears this liner at home for about 4 weeks and provides feedback on the prototype.
Modified Dermatology Life Quality Index (mDLQI)	7 units on a scale

Adverse Events

Experimental Prosthetic Liner

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brianna Rozell

Liberating Technologies, Inc.

Phone: 774-233-0876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place