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N/A N=60 Basic Science

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

Lower Limb Amputation

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Ratio of Trans-epidermal Water Loss (TEWL) at 16 Weeks After Use — 1.69 ratio — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Active vacuum test prosthesis (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Indiana University
Primary completion
Aug 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Ratio of Trans-epidermal Water Loss (TEWL) at 16 Weeks After Use
1.69 <0.05 sig
SECONDARY
Change in Hyperspectral Imaging at 16 Wks
1.2
SECONDARY
Ultrasound Measurements at 16 Wks
1.2508 0.05

Summary

The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket. The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented. This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.

Eligibility Criteria

Inclusion Criteria

  • Ages of 18 and above
  • Unilateral transtibial or transfemoral amputee
  • Ambulate at a K2 level or higher
  • At least 3 months post-amputation per physician discretion
  • Residual limb length greater than 6.5 inches in length
  • Able to follow directions and give informed consent on their own or through Legally Authorized Representative.
  • Must be able to ambulate without assistance. An external assistance device such as cane or walker will be permitted.
  • Adequate arterial blood flow as evidenced by a TcOM >30mmHg measured within the past 12 months.

Exclusion Criteria

  • Conditions that prevent wearing a prosthetic socket,such as existing scab, ulcer, or keloid scar on amputation stump.
  • Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
  • Women who are pregnant or who plan to become pregnant in the near future
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03927404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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