Lower Limb Amputation Clinical Trial
Official title:
Prosthetic Socket System: Pilot Assessment
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consenting Adult - Unilateral lower extremity amputee - Currently using a liner with prosthesis - Uses a prosthesis to ambulate - Ability to read, write and understand English - Available during regular business hours for appointments Exclusion Criteria: - Impaired contra lateral leg - Uses vacuum suspension with their current prosthesis - Diagnosis of renal failure - Smoker |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Davis Heart and Lung Research Institute | Columbus | Ohio |
United States | The Ohio Willow Wood Company | Mt. Sterling | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio Willow Wood | Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Skin temperature values at 8wk | 8 weeks | No | |
Other | Prosthesis evaluation questionnaire (PEQ) | 16 weeks | No | |
Primary | Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks | Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks | 16 weeks | No |
Secondary | Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks | Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks | 8 weeks | No |
Secondary | Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks | Change from baseline in Hyperspectral Imaging StO2% at 8wks | 8 weeks | No |
Secondary | Hyperspectral Imaging StO2% at 16wks | change from baseline in Hyperspectral Imaging StO2% at 16wks | 16 weeks | No |
Secondary | Laser speckle flowmetry tissue perfusion values at 8wks | Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks | 8 weeks | No |
Secondary | Laser speckle flowmetry tissue perfusion values at 16wks | Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks | 16 weeks | No |
Secondary | Laser Doppler flowmetry tissue perfusion values at 8wks | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks | 8 weeks | No |
Secondary | Laser Doppler flowmetry tissue perfusion values at 16wks | Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks | 16 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04275973 -
Evaluating Mobility Interventions in the Real World
|
N/A | |
Completed |
NCT01953939 -
Outcome Measures for Lower Limb Amputees - A Repeatability Study
|
N/A | |
Completed |
NCT01946321 -
Outcome Measures for Lower Limb Amputees - A Rehabilitation Study
|
N/A | |
Recruiting |
NCT04030650 -
Study of Locomotor Expectations for Ascending/Descending Slope and Stairs in Patients With Limb Amputations
|
||
Completed |
NCT04141748 -
Comparative Effectiveness of Socket Casting Methods: Improving Form and Fit
|
N/A | |
Enrolling by invitation |
NCT05807607 -
Study of Lower-limb Phantom Pain Syndrome Using Peripheral Nerve and Spinal Cord Stimulation
|
N/A | |
Completed |
NCT03260530 -
Overall Functional Evaluation After Amputation of the Lower Limb; Locomotion, Energy Efficiency and Strategies to Adapt to the Prosthesis
|
||
Completed |
NCT03409354 -
Tele-Rehabilitation Pilot Evaluation Study
|
N/A | |
Recruiting |
NCT05830630 -
Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery
|
N/A | |
Recruiting |
NCT01846845 -
Evaluation of a Novel Transfemoral Prosthetic Socket System
|
N/A | |
Completed |
NCT06160336 -
Transcutaneous Electrical Stimulation in Lower Limb Amputees
|
N/A | |
Not yet recruiting |
NCT06415955 -
Identification of Limiting Factors in the Locomotor Activity of Individuals With Lower Limb Amputation:
|
||
Recruiting |
NCT05880251 -
Operant Conditioning of Sensory Brain Responses to Reduce Phantom Limb Pain in People With Limb Amputation
|
N/A | |
Completed |
NCT04285138 -
Phantom Exercise for Lower Limb Amputees
|
N/A | |
Completed |
NCT01715662 -
A Pilot RCT to Investigate the Use of a Home-based Nintendo Wii Program for Rehabilitation in Older Adults With Lower Limb Amputation
|
N/A | |
Withdrawn |
NCT04086069 -
Sit-to-stand Trainer in Patients After Lower Limb Amputation
|
N/A | |
Completed |
NCT04293237 -
Metric Charcteristics of Sit-to-stand Tests in Patients After Lower-limb Amputation
|
||
Recruiting |
NCT06276179 -
Epidural Oxycodone for Pain Management for Lower Limb Amputation
|
N/A | |
Not yet recruiting |
NCT01748435 -
Pre-emptive Analgesia With Qutenza in Lower Limb Amputation
|
N/A | |
Completed |
NCT05224232 -
Protocole Access-Socket
|
N/A |