An interventional study of Standard-of-Care and Clinical Screening in Limb Ischemia, Low Back Pain and Depression, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by University of Delaware · Not applicable, Interventional, and Screening
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →University of Delaware is the lead sponsor of 128 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient participants will receive routine standardized prosthetic follow-up care by a certified prosthetist, including evaluation of prosthesis use, prosthesis-enabled mobility, socket comfort and sock ply usage, falls, body anthropometrics, and functional mobility.
Other: Standard-of-Care
In addition to routine, standardized prosthetic follow-up care, patient participants will receive comorbidity screening for contralateral limb peripheral arterial disease, peripheral neuropathy, major depression, and greater than low risk for persistent low back pain. Participants will be educated on clinical screening findings, provided a copy of their screening results to share with their medical providers, and their results will be securely sent to their primary care provider.
Other: Standard-of-Care · Other: Clinical Screening
Participants with a major unilateral transfemoral or transtibial amputation will undergo a standardized medical history and medication review, complete questionnaires evaluating prosthesis use, comfort, and mobility, receive a clinical examination of height, weight and limb circumference, and complete three performance-based mobility outcome measures.
Participants will complete the following self-report questionnaires: (a) the Patient Health Questionnaire-9 item, which may suggest major depression and/or suicidal ideation; and (b) the STarT Back Screening Tool, a 6-item tool used to screen for greater than low-risk for persistent, bothersome and disabling low back pain. Prosthetists will perform palpation of the contralateral dorsalis pedis and posterior tibial pulses and note presence or absence, as an indicator of peripheral arterial disease. Prosthetists will evaluate protective sensation of the contralateral foot through Semmes-Weinstein monofilament assessment of the great toe, the 1st and 3rd metatarsal heads. The prosthetist will record the results in a letter that is sent to the patient's primary care provider, and provide a copy of the letter to the patient after discussing the results for each of the screens.
Orthotic and Prosthetic Limb User Survey of Mobility (OPUS): Satisfaction with Device and Services
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).
Time frame: 3-month follow-up
Client Satisfaction Inventory-short form
This 9-item survey assesses how the individual feels about the services they have received. Items are rated from 1 (none of the time) to 7 (all of the time) and summed for a total possible score of 7-63. Higher scores indicate greater satisfaction.
Time frame: 3-month follow-up
Prosthetic service utilization
Number of patient care minutes extracted from each participant's electronic medical record
Time frame: through study completion, an average of 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified patient participant data are available from the corresponding author upon reasonable request and with completion of a data use agreement to protect participant confidentiality.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Individual patient participant data that underlie results will be available beginning 3 months following publication of the primary results and ending 5 years following publication of the primary results to researchers who provide a methodologically sound proposal and complete a data sharing agreement.
Access criteria: Proposals should be directed to J. Megan Sions, PT, DPT, PhD, the study's principal investigator, in writing at megsions@udel.edu. To gain access to individual patient participant data, requestors will need to sign a data access agreement with the principal investigator's home institution, i.e., the University of Delaware.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.