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Search / Trial NCT04083456

Dysvascular Amputation Self-Management of Health

Launched by UNIVERSITY OF COLORADO, DENVER · Sep 5, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Amputation Dysvascular Amputation Diabetes Peripheral Artery Disease Physical Activity

ClinConnect Summary

This clinical trial is looking at whether a specific walking program can help people who have had lower limb amputations due to diabetes or blood circulation issues to be more active. The study aims to see if this program can improve physical activity levels in participants who are aged between 50 and 85 years and have had their leg amputated within the last year. To qualify for the trial, participants must have a confirmed diagnosis of Type II diabetes or a condition called Peripheral Artery Disease, and they should be able to aim for walking around their home with the help of a prosthetic leg.

Participants in the study can expect to engage in a walking intervention program designed to help them increase their physical activity safely. The trial is currently recruiting individuals and is open to all genders. However, certain people may not qualify, such as those who have had amputations due to trauma or cancer, individuals with serious cognitive challenges, or those undergoing active cancer treatment. This study is important because it could lead to better ways for amputees to manage their health and improve their quality of life through increased mobility.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Within the age range of 50-85 years
  • Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
  • Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
  • Participant goal of household walking or better using a prosthesis
  • 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 determined to be unsafe and/or inappropriate to participate in the described intervention.

About University Of Colorado, Denver

The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.

Locations

Aurora, Colorado, United States

Patients applied

0 patients applied

Trial Officials

Cory Christiansen, PT, PhD

Principal Investigator

University of Colorado, Denver

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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