Diabetes Clinical Trial
Official title:
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
Verified date | July 2014 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The fit of the residual limb within a prosthetic socket is a primary concern for many
amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further,
amputees with diabetes or vascular dysfunction often have difficulty maintaining healthy
residual limb tissue; a condition that could be mitigated by the application of negative
pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual
limb response to a vacuum suspension system and to measure prosthetic performance in
comparison to a typical suction suspension system.
The proposed research plan involves two sets of human subject experiments: (1) prospective,
randomized cross-over study to quantify performance of a vacuum suspension system as
compared to a total surface bearing suction socket in terms of pistoning, maintaining limb
volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous
oxygen tension as a function of vacuum pressure.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Over 18 and less than 70 years of age, - Have a below knee amputation involving only one side, - If the cause of amputation was for traumatic reasons and do not have diabetes or a vascular condition, the amputation must have occurred at least six months ago and the potential subject must have worn a prosthesis for at least four months, - If the cause of amputation was for diabetes or vascular reasons, the potential subject must have been fit with a prosthesis and have worn it for at least one year, - Wear the prosthesis for at least 6 hours a day, - Able to walk without a cane, crutches, or a walker, - Are moderately active enough to walk at a steady pace for at least 30 minutes. Exclusion Criteria: - Have pain in legs or any condition that interferes with walking. - Have an ulcer on the residual limb, - If potential subject had an amputation because of a tumor or an infection, no longer have an active tumor or undergoing treatment for a tumor, - Have fallen within the last 3 months. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System, Seattle | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Limb Volume | Measurements were taken after wearing the study prostheses for three weeks | No | |
Primary | Activity Level | Total number of steps during a two week period ending in the fourth week for each study prosthesis (PIN and VASS). | Two weeks | No |
Primary | Limb Pistoning | Limb pistoning is the change in the resultant distance between the prosthetic-side knee joint marker triad and the residual limb thigh triad measured using a 12-camera motion analysis system while subjects weighted and un-weighted their prosthesis standing in place. | Measurements were taken after wearing the study prosthesis for three weeks | No |
Secondary | Residual Limb Health (PEQ Scale) | Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Residual Limb Health scale examines: sweat, smell, volume changes, rashes, ingrown hairs, and blisters. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., most healthful). | Measurements were taken after wearing the study prosthesis for four weeks | No |
Secondary | Ambulation (PEQ Scale) | Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. The Ambulation scale queries the ability to walk in general, in close spaces, on stairs and ramps, in urban environments, and on slippery surfaces. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., easiest to walk on). | Measurements were taken after wearing the study prosthesis for four weeks | No |
Secondary | Frustration (PEQ Scale) | Qualitative differences between the study limbs were assessed using the Prosthesis Evaluation Questionnaire (PEQ). This standardized, self-report instrument is specific to persons with lower limb amputations and is used to evaluate prosthetic care with regard to prescription and prosthesis-related quality of life. Frustration was assessed by frequency of occurrence and rating. The scale is scored from 0 to 100 where 100 indicates the best outcome (i.e., least frustrating). | Measurements were taken after wearing the study prosthesis for four weeks | No |
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