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NCT05410548 · ClinicalTrials.gov registry record · NA
Comorbidity Screening and Referral by Prosthetists
A NA study, sponsored by University of Delaware.
- Completed
- Registry status
- NA
- Development phase
- 70
- Enrollment target
NCT05410548: Completed NA study, sponsored by University of Delaware.
NCT05410548 is a NA study that has completed, run by University of Delaware. The registered enrollment target is 70 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05410548, a NA study, has completed, sponsored by University of Delaware.
- COMPLETED
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
Study 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. 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.
Primary Outcome
This questionnaire evaluates device function, fit, and cosmesis, as well as education, timeliness, and courtesy of the practitioner through 21 items. Items are scored on a 5-point Likert scale and higher scores indicate greater satisfaction. Items 1-11 are summed for the Satisfaction with Device subscale score (range: 11-55) and items 12-21 are summed for the Satisfaction with Services subscale score (range: 10-50).
Interventions
- OTHER Standard-of-Care
- OTHER Clinical Screening
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-06-09 |
| Est. Completion | 2023-01-30 |
| Phase | NA |
What the finished NCT05410548 record still lists
NCT05410548 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard-of-Care is the first listed.
NCT05410548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05410548 about?
NCT05410548 is a clinical study titled "Comorbidity Screening and Referral by Prosthetists". 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 L...
What is the current status of trial NCT05410548?
This trial is currently completed. It is a NA study. The enrollment target is 70 participants. The study started on 2022-06-09. Estimated completion is 2023-01-30.
What interventions are being tested in trial NCT05410548?
The interventions under investigation include: Standard-of-Care (OTHER), Clinical Screening (OTHER).
Who is sponsoring clinical trial NCT05410548?
This trial is sponsored by University of Delaware, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05410548's enrollment target sits among peer trials
70 1103rd of 2000 higher than 868 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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