Dysvascular Amputation Self-Management of Health

Last updated: July 28, 2025
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

2

Condition

Diabetes Prevention

Peripheral Arterial Occlusive Disease

Diabetes And Hypertension

Treatment

Walking Biobehavioral Intervention

Attention Control

Clinical Study ID

NCT04083456
19-0534
R01NR018450
  • Ages 50-85
  • All Genders

Study Summary

The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Within the age range of 50-85 years

  • Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral ArteryDisease (PAD)

  • Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (orre-amputation) within the past 12 months

  • Participant goal of household walking or better using a prosthesis

Exclusion

Exclusion Criteria:

  • Trauma or cancer-related etiology of the LLA

  • Decisionally challenged individuals (MMSE score below 24)

  • Prisoners

  • Active cancer treatment

  • Recent stroke (within 2 years)

  • Clinical discretion of principal investigator to exclude patients who are determinedto be unsafe and/or inappropriate to participate in the described intervention.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Walking Biobehavioral Intervention
Phase: 2
Study Start date:
November 01, 2019
Estimated Completion Date:
May 31, 2025

Study Description

Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.

Connect with a study center

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Site Not Available

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