Status:

COMPLETED

Comorbidity Screening and Referral by Prosthetists

Lead Sponsor:

University of Delaware

Collaborating Sponsors:

Independence Prosthetics-Orthotics, Inc.

Orthotic and Prosthetic Education and Research Foundation (OPERF)

Conditions:

Limb Ischemia

Low Back Pain

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

Lower-limb amputation is associated with life-altering and life-limiting comorbidities. Currently, onus is on primary care providers to diagnose, educate, and refer patients for appropriate management...

Eligibility Criteria

Inclusion

  • English-speaking and -reading
  • Unilateral transtibial (i.e., below-knee) or transfemoral (i.e., above-knee) amputation
  • Utilization of a prosthesis for at least 1 year
  • Willingness to have screening results communicated to their primary care provider
  • Receiving prosthetic care at Independence Prosthetics-Orthotics, Inc.

Exclusion

  • Cognitive impairment precluding ability to consent to study participation
  • Contralateral limb amputation greater than toe-level
  • Severe vision or hearing loss
  • Receipt of a replacement prosthetic component within the 3 months prior to study enrollment
  • Hospitalization within the 3 months prior to study enrollment

Key Trial Info

Start Date :

June 9 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 30 2023

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT05410548

Start Date

June 9 2022

End Date

January 30 2023

Last Update

December 31 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of Delaware STAR Campus

Newark, Delaware, United States, 19713