Trial Outcomes & Findings for Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health (NCT NCT03927404)

Last Updated: 2024-05-24

Results Overview

Trans-epidermal Water Loss in 16 wks. Higher TEWL value represents a worse outcome with loss of skin barrier function. The value reported is the ratio of the TEWL of residual limb over TEWL value of the sound side limb.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Baseline and 16 Weeks

Results posted on

2024-05-24

Participant Flow

The subjects were enrolled at CWC Methodist Indiana University Health and Willow Wood Ohio

any subject did not meet the blood perfusion eligibility criteria were screened failed

Participant milestones

Participant milestones
Measure	Adaptive Vacuum Test Prosthesis This is a crossover study design where participant come in their standard of care socket suspension system and the baseline measurements are performed followed by a 16 week period in the experimental socket system that uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion. Active vacuum test prosthesis: The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Overall Study STARTED	60
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Adaptive Vacuum Test Prosthesis This is a crossover study design where participant come in their standard of care socket suspension system and the baseline measurements are performed followed by a 16 week period in the experimental socket system that uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion. Active vacuum test prosthesis: The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adaptive Vacuum Test Prosthesis n=59 Participants The experimental socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion. Active vacuum test prosthesis: The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	59 Participants n=5 Participants
Age	57 years n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 Weeks

Population: A total of n=60 subjects were enrolled at IU (n=30) and WW (n=30) sites. One enrolled subject discontinued and therefore n=59 subjects were analyzed. The studies initiated mid-2019, however, due to global pandemic research activities were greatly affected at both sites. The studies were on hold and got reinitiated fall of 2020 at IU and WW sites. Declaration of Helsinki protocols was followed, and patients gave their written informed consent.

Outcome measures

Outcome measures
Measure	Adaptive Vacuum Test Prosthesis n=59 Participants The experimental socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion. Active vacuum test prosthesis: The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Ratio of Trans-epidermal Water Loss (TEWL) at 16 Weeks After Use	1.69 ratio Interval 1.12 to 2.85

SECONDARY outcome

Timeframe: Baseline to16 weeks

Population: total of n=60 subjects were enrolled at IU (n=30) and WW (n=30) sites. One enrolled subject discontinued and therefore n=59 subjects were analyzed. The studies initiated mid-2019, however, due to global pandemic research activities were greatly affected at both sites. The studies were on hold and got reinitiated fall of 2020 at IU and WW sites. Declaration of Helsinki protocols was followed, and patients gave their written informed consent.

Change from baseline in Hyperspectral Imaging at 16 wks; tissue oxygenation measured using hyperspectral imaging. Higher the HbO2 better is the perfusion in skin indicating less damage.

Outcome measures

Outcome measures
Measure	Adaptive Vacuum Test Prosthesis n=59 Participants The experimental socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion. Active vacuum test prosthesis: The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Change in Hyperspectral Imaging at 16 Wks	1.2 Percentage of Oxygen Interval 0.55 to 2.94

SECONDARY outcome

Timeframe: 16 weeks

Population: A total of n=60 subjects were enrolled at IU (n=30) and WW (n=30) sites. The data that passed QC for the analysis was n=23 used for final data.

In elasto-mode the blue color represents less elastic skin and weak tensile strength. whereas red is more elastic skin and high tensile strength. The blue \& red color intensities in elasto mode were calculated in Matlab as arbitrary units (AU). The data presented is median of the AU. A lower AU meaning better tensile strength of the tissue meaning favorable outcome.

Outcome measures

Outcome measures
Measure	Adaptive Vacuum Test Prosthesis n=23 Participants The experimental socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion. Active vacuum test prosthesis: The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
Ultrasound Measurements at 16 Wks	1.2508 Arbitrary Units (AU) Interval 0.856 to 1.88

Adverse Events

Adaptive Vacuum Test Prosthesis

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

Dr. Sashwati Roy

University of Pittsburgh

Phone: 412-648-8297

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place