Status:

COMPLETED

Skin Temperature Perception and Prosthetic Thermoregulation

Lead Sponsor:

VA Puget Sound Health Care System

Conditions:

Lower Limb Amputation Below Knee

Diabetes (DM)

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

To protect against excessive body temperatures, local thermoregulatory mechanisms include temperature sensory nerves (responsive to warm or cool stimuli) and vasomotors (muscles that constrict or dila...

Detailed Description

This study will include four groups of participants including individuals with diabetes, individuals without a diagnosis of diabetes, individuals with lower limb amputations of diabetic etiology, and ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria for All Participants:
  • Able to ambulate without upper extremity aids
  • Able to attend study visits
  • Able to sense a Semmes-Weinstein 5.07 monofilament applied to proximal lateral aspect of test limb calf
  • Cognitively aware Additional Inclusion Criteria for Individuals with Lower Limb Amputation
  • Have been fit with a prosthesis
  • Have used a prosthesis for at least six months
  • Wear the prosthesis for at least four hours per day by self-report
  • Exclusion Criteria for Individuals with Lower Limb Amputation:
  • \- Have no residual limb ulcers

Exclusion

    Key Trial Info

    Start Date :

    April 28 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 9 2013

    Estimated Enrollment :

    56 Patients enrolled

    Trial Details

    Trial ID

    NCT07215442

    Start Date

    April 28 2011

    End Date

    August 9 2013

    Last Update

    October 10 2025

    Active Locations (1)

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    VA Puget Sound Health Care System Seattle Division

    Seattle, Washington, United States, 98108