NCT00985842

Brief Summary

Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

September 29, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2012

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

3 years

First QC Date

December 11, 2007

Last Update Submit

June 28, 2018

Conditions

AmputationDiabetes ComplicationsLeg InjuriesTraumatic Amputation

Keywords

Artificial limbsGaitOximetryProsthesisRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Oxygen in tissue

    Tissue oxygen saturation (StO2)

    Comparison of five different systems will be performed in one session occurring on one day

Study Arms (1)

Arm 1

OTHER

Comparison of five different clinically used suspension and socket systems

Device: Pe-Lite and sleeve suspension socketDevice: Total Surface bearing a socket with a sleeve suspension but without suctionDevice: Total surface bearing suction socket with a pin lock suspensionDevice: Total surface bearing suction socket with a sleeve suspensionDevice: Vacuum-assisted socket system (Harmony System, Otto Bock)

Interventions

Pe-Lite and sleeve suspension socketDEVICE

Prosthetic socket worn by the amputee that has a Pe-lite foam liner between the socket and the residual limb. It is suspended from the residual limb using a sleeve at the top of the socket.

Arm 1
Total Surface bearing a socket with a sleeve suspension but without suctionDEVICE

Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a sleeve at the top of the socket.

Arm 1
Total surface bearing suction socket with a pin lock suspensionDEVICE

Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket is suspended from the residual limb using a pin that protrudes from the bottom of the liner into the socket that is then locked in place by the amputee.

Arm 1
Total surface bearing suction socket with a sleeve suspensionDEVICE

Prosthetic socket worn by the amputee where the fit of the socket touches every part of the residual limb. This socket using vacuum suction plus a sleeve at the top of the prosthetic socket to enhance the security of the suspension.

Arm 1
Vacuum-assisted socket system (Harmony System, Otto Bock)DEVICE

Prosthetic socket worn by the amputee where the a vacuum pump, in this case a mechanically-activated pump, creates a vacuum between the socket and the limb. This vacuum suspends the prosthetic limb from the amputee's residual limb.

Arm 1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral transtibial amputee of diabetic etiology between the ages of 18 and 70,
  • have been fit with a prosthesis and have used a prosthesis for at least one year,
  • wear the prosthesis at least 4 hours per day,
  • ambulate without upper extremity aids, and
  • have no history of injurious falls within the previous six months.

You may not qualify if:

  • Subjects will be excluded if:
  • they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics or
  • their residual limb is ulcerated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes ComplicationsLeg InjuriesAmputation, Traumatic

Interventions

Suction

Condition Hierarchy (Ancestors)

Diabetes MellitusEndocrine System DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

DrainageSurgical Procedures, Operative

Study Officials

  • Glenn K Klute, PhD

    VA Puget Sound Health Care System Seattle Division, Seattle, WA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2007

First Posted

September 29, 2009

Study Start

November 1, 2009

Primary Completion

October 26, 2012

Study Completion

October 26, 2012

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)