Comorbidity Screening and Referral by Prosthetists
Completed · Not applicable
Conditions studied: Limb Ischemia, Low Back Pain, Depression, Neuropathy;Peripheral, Amputation
In brief
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. Recently our laboratory has found, however, that of adults post-amputation seen in an outpatient Limb Loss Clinic presenting with comorbidities, \>50% are unaware they have signs of peripheral arterial disease and/or neuropathy. Lack of patient awareness and thus, inadequate comorbidity management, may contribute to suboptimal patient outcomes post-amputation. As a first step in this research line, the proposed project will help determine if comorbidity screening by prosthetists during routine care visits for patients post-amputation may enhance comorbidity awareness, increase patient satisfaction in prosthetic services, and reduce gratuitous prosthetic service utilization. During a follow-up visit, seventy patients following a unilateral lower-limb amputation will be randomized into either a standard-of-care group or a standard of-care plus group. The standard-of-care plus group will receive clinical screenings by a certified prosthetist for peripheral arterial disease, peripheral neuropathy, depression, and high-risk for persistent back pain; patient education on findings; and each participant's primary care provider will receive screening results. The long-term goal of this research is to determine if prosthetists can maximize their utility in an interdisciplinary care team, while enhancing patient outcomes post-amputation.
Key facts
- Study ID
- NCT05410548
- Run by
- University of Delaware
- People needed
- 70
- Starts
- 2022-06-09
- Expected to finish
- 2023-01-30
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Delaware STAR Campus — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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