Trial Outcomes & Findings for Effects of Temperature Control Liner Materials on Long-Term Outcomes of Prothesis Use (NCT NCT03428815)
NCT ID: NCT03428815
Last Updated: 2021-03-05
Results Overview
Days with less than 10% of prosthesis steps than the individual's daily average across the study period. Days without prosthesis are prorated to a full year (365 days) for comparison purposes.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
6 months
Results posted on
2021-03-05
Participant Flow
Six participants did not start the protocol: Four had an incompatibility of study liners with their existing socket prosthesis, one had an unrelated health issue, and one was unreachable after enrollment.
Participant milestones
| Measure |
First PCM Liner, Then Regular Liner
Prosthesis suspension liner: Liners out of phase change material (Willowwood Smart Temp Liner) are fitted first. After 6 months they are exchanged against a set of regular liners
|
First Regular Liner, Then PCM Liner
Prosthesis suspension liner: Participants' regular liners are fitted first. After 6 months they are exchanged against a set of phase change material liners (Willowwood Smart Temp Liner)
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
7
|
14
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
First PCM Liner, Then Regular Liner
Prosthesis suspension liner: Liners out of phase change material (Willowwood Smart Temp Liner) are fitted first. After 6 months they are exchanged against a set of regular liners
|
First Regular Liner, Then PCM Liner
Prosthesis suspension liner: Participants' regular liners are fitted first. After 6 months they are exchanged against a set of phase change material liners (Willowwood Smart Temp Liner)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
suspension of study activities due to Covid-19 pandemic
|
5
|
2
|
|
Overall Study
Intermittent fitting issues that affected reliability of data
|
3
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PCM Liner
n=17 Participants
Willowwood Smart Temp Liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
Regular Liner
n=19 Participants
User's regular prescribed liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 13 • n=17 Participants
|
59 years
STANDARD_DEVIATION 11 • n=19 Participants
|
57 years
STANDARD_DEVIATION 12 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=17 Participants
|
6 Participants
n=19 Participants
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=17 Participants
|
13 Participants
n=19 Participants
|
28 Participants
n=36 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
19 participants
n=19 Participants
|
36 participants
n=36 Participants
|
|
Height
|
181 cm
STANDARD_DEVIATION 7 • n=17 Participants
|
175 cm
STANDARD_DEVIATION 11 • n=19 Participants
|
178 cm
STANDARD_DEVIATION 10 • n=36 Participants
|
|
Weight
|
97 kg
STANDARD_DEVIATION 23 • n=17 Participants
|
99 kg
STANDARD_DEVIATION 24 • n=19 Participants
|
98 kg
STANDARD_DEVIATION 23 • n=36 Participants
|
|
Years since limb loss
|
8 years
STANDARD_DEVIATION 7 • n=17 Participants
|
10 years
STANDARD_DEVIATION 12 • n=19 Participants
|
9 years
STANDARD_DEVIATION 10 • n=36 Participants
|
|
Mobility score (z-score, PLUS-M)
|
57 units on a scale
STANDARD_DEVIATION 6 • n=17 Participants
|
55 units on a scale
STANDARD_DEVIATION 8 • n=19 Participants
|
56 units on a scale
STANDARD_DEVIATION 7 • n=36 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: only participants with data from both interventions (cross-over design) was included
Days with less than 10% of prosthesis steps than the individual's daily average across the study period. Days without prosthesis are prorated to a full year (365 days) for comparison purposes.
Outcome measures
| Measure |
PCM Liner
n=21 Participants
Willowwood Smart Temp Liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
Regular Liner
n=21 Participants
User's regular prescribed liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
|---|---|---|
|
Days Without Prosthesis
|
17 prorated days per year
Interval 0.0 to 21.0
|
19 prorated days per year
Interval 0.0 to 35.0
|
SECONDARY outcome
Timeframe: 6 months per interventionA participant's daily step counts were averaged across days with prosthesis use across each intervention period
Outcome measures
| Measure |
PCM Liner
n=21 Participants
Willowwood Smart Temp Liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
Regular Liner
n=21 Participants
User's regular prescribed liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
|---|---|---|
|
Average Daily Step Count
|
2053 steps per day
Standard Deviation 1249
|
2117 steps per day
Standard Deviation 1176
|
Adverse Events
PCM Liner
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Regular 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
| Measure |
PCM Liner
n=29 participants at risk
Willowwood Smart Temp Liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
Regular Liner
n=33 participants at risk
User's regular prescribed liner
Prosthesis suspension liner: Liners out of phase change material will be fitted
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.4%
1/29 • Number of events 1 • 1 year
Of the 42 participants that were enrolled (i.e., screened and signed the consent form), 36 received liners (19 received the PCM liner first and 17 received the regular liner first). After some attrition, 16 of the first group received the regular liner and ten of the second group received the PCM liner. Therefore, a total of 29 participants were exposed to the PCM liner and 33 to the regular liner during the study.
|
0.00%
0/33 • 1 year
Of the 42 participants that were enrolled (i.e., screened and signed the consent form), 36 received liners (19 received the PCM liner first and 17 received the regular liner first). After some attrition, 16 of the first group received the regular liner and ten of the second group received the PCM liner. Therefore, a total of 29 participants were exposed to the PCM liner and 33 to the regular liner during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place