N/A
Completed N=17
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
Amputation · Diabetes · Leg Injuries · Traumatic Amputations
Source: ClinicalTrials.gov NCT00117793 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcomePrimary: Limb Volume — 0.68; 0.72 liters — p=>0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Limb Volume |
0.68; 0.72 | >0.05 |
| PRIMARY Activity Level |
73; 38 | =0.0056 sig |
| PRIMARY Limb Pistoning |
6; 1 | =0.0021 sig |
| SECONDARY Residual Limb Health (PEQ Scale) |
90; 77 | — |
| SECONDARY Ambulation (PEQ Scale) |
95; 67 | — |
| SECONDARY Frustration (PEQ Scale) |
91; 43 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00117793). 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. Informational only — not medical advice.