Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit

NCT00117793 | Completed Results

• 1 other identifier: A3666
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amputation; Diabetes; Leg Injuries; Traumatic Amputations

Keywords

Amputee; Artificial limbs; Gait; Walking

Outcome Measures

Primary Outcomes (3)

• Limb Volume

  Measurements were taken after wearing the study prostheses for three weeks

• 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

• 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

Secondary Outcomes (3)

• Residual Limb Health (PEQ Scale)

  Measurements were taken after wearing the study prosthesis for four weeks

• Ambulation (PEQ Scale)

  Measurements were taken after wearing the study prosthesis for four weeks

• Frustration (PEQ Scale)

  Measurements were taken after wearing the study prosthesis for four weeks

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Current clinical practice

Device: Total Surface Bearing Suction Socket

Arm 2

EXPERIMENTAL

Novel socket system

Device: Vacuum assisted socket system

Interventions

Total Surface Bearing Suction Socket DEVICE

Current clinical practice

Arm 1

Vacuum assisted socket system DEVICE

Novel socket system

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Klute GK, Berge JS, Biggs W, Pongnumkul S, Popovic Z, Curless B. Vacuum-assisted socket suspension compared with pin suspension for lower extremity amputees: effect on fit, activity, and limb volume. Arch Phys Med Rehabil. 2011 Oct;92(10):1570-5. doi: 10.1016/j.apmr.2011.05.019.

  PMID: 21963124 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Leg Injuries; Amputation, Traumatic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Wounds and Injuries

Limitations and Caveats

The small number of participants who completed the protocol precluded a statistical analysis on the secondary outcome measures.

Results Point of Contact

• Title: Glenn K. Klute, PhD
• Organization: Dept. of Veterans Affairs, Rehabilitation Research & Development Service

Glenn.Klute@va.gov

206-277-6724

Study Officials

• Glenn K. Klute, PhD

  VA Puget Sound Health Care System, Seattle

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2005
• First Posted: July 8, 2005
• Study Start: August 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

US (1)