Amputation Clinical Trial
Official title:
Socket System Effect on Tissue Oxygenation During Amputee Gait
Verified date | June 2018 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | October 26, 2012 |
Est. primary completion date | October 26, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: All subjects must meet the following inclusion criteria: - 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | University of Washington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxygen in tissue | Tissue oxygen saturation (StO2) | Comparison of five different systems will be performed in one session occurring on one day |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03947450 -
Autologous Volar Fibroblast Injection Into the Stump Site of Amputees
|
Phase 2 | |
Completed |
NCT04924036 -
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
|
Phase 2 | |
Recruiting |
NCT04839497 -
Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.
|
Phase 2 | |
Recruiting |
NCT04212299 -
Transfemoral Socket Design and Muscle Function
|
N/A | |
Completed |
NCT03733054 -
Understanding Prosthetic Needs and Outcomes in Women Veterans With Amputation
|
||
Completed |
NCT03651830 -
A Test-Drive Strategy for the Prescription of Prosthetic Feet for People With Leg Amputations
|
N/A | |
Recruiting |
NCT04725006 -
Sensory Responses to Dorsal Root Stimulation
|
N/A | |
Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
Not yet recruiting |
NCT04936789 -
Clinical Feasibility of the IMES Transradial Prosthesis
|
N/A | |
Completed |
NCT01155024 -
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
|
Phase 2 | |
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Terminated |
NCT00778856 -
Hand Transplantation for the Reconstruction of Below the Elbow Amputations
|
N/A | |
Recruiting |
NCT00388752 -
Acupuncture for the Treatment of Phantom Limb and Residual Limb Pain After Amputation
|
Phase 1 | |
Active, not recruiting |
NCT03374319 -
Somatotopic Configuration of Distal Residual Limb Tissues in Lower Extremity Amputations
|
N/A | |
Completed |
NCT05542901 -
Comparison of Joint Position Sense in Diabetic and Traumatic Transtibial Amputees
|
N/A | |
Completed |
NCT05161364 -
Kinetic Analysis Due to Foot Dysfunction
|
||
Recruiting |
NCT06194838 -
Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees
|
N/A | |
Completed |
NCT03570788 -
HRQoL Among Patients Amputated Due to Peripheral Arterial Disease
|
||
Completed |
NCT05778799 -
Physical Activity and Sports for People With Special Needs
|
||
Recruiting |
NCT04804150 -
Daily Socket Comfort in Transtibial Amputee With an Active Vacuum Suspension System
|
N/A |