Limb IschemiaNCT05410548
Comorbidity Screening and Referral by Prosthetists
A study testing Standard-of-Care and Clinical Screening in people with Limb Ischemia and Low Back Pain, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Limb Ischemia, Low Back Pain, Depression
- What is being tested?
- Standard-of-Care and Clinical Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Delaware STAR Campus
Newark, Delaware, 19713
About this study
Official title: Can Comorbidity Screening and Referral by Prosthetists Enhance Post-Amputation Care?
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.
- Conditions
- Limb Ischemia, Low Back Pain, Depression, Neuropathy;Peripheral, Amputation
- Being tested
- Standard-of-Care, Clinical Screening
- Keywords
- comorbidity, peripheral arterial disease, sensation, back pain, mental health, amputation
- Medical subject headings
- Low Back Pain, Depression, Neuritis, Peripheral Arterial Disease, Back Pain, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-CareOther
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.
Clinical ScreeningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care | Other | 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. Receives: Other: Standard-of-Care |
| Standard-of-Care + Clinical Screening | Experimental | 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. Receives: Other: Standard-of-Care; Other: Clinical Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3-month follow-up
Prosthetic service utilization
Number of patient care minutes extracted from each participant's electronic medical record
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start9 Jun 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Independence Prosthetics-Orthotics, Inc., Orthotic and Prosthetic Education and Research Foundation (OPERF)
- Responsible party
- Principal investigator, Jaclyn Sions, University of Delaware
- Investigators
- Jaclyn M Sions, PhD, DPT, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410548
- Sponsor's protocol ID
- 1865677
- Status last verified
- May 2023
- First submitted
- 2 Jun 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Sions JM, Stauffer SJ, Horne JR, Pohlig RT. Prosthetist screening for comorbidity during routine care visits: a randomised controlled clinical trial evaluating benefits, acceptability and feasibility. BMJ Open. 2026 Feb 27;16(2):e108623. doi: 10.1136/bmjopen-2025-108623.
PubMed 41760154
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Comorbidity Screening and Referral by Prosthetists Enhance Post-Amputation Care?
- ClinicalTrials.gov ID
- NCT05410548
- Acronym / sponsor ID
- 1865677
- Conditions
- Limb Ischemia, Low Back Pain, Depression, Neuropathy;Peripheral, Amputation
- Keywords
- comorbidity, peripheral arterial disease, sensation, back pain, mental health, amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Independence Prosthetics-Orthotics, Inc., Orthotic and Prosthetic Education and Research Foundation (OPERF)
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care | Other | Other: Standard-of-CarePatient 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. |
| Standard-of-Care + Clinical Screening | Experimental | Other: Standard-of-Care, Other: Clinical ScreeningIn 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard-of-CareParticipants 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. | Other | Standard-of-Care, Standard-of-Care + Clinical Screening |
| Clinical ScreeningParticipants 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. | Other | Standard-of-Care + Clinical Screening |
Primary outcome
Orthotic and Prosthetic Limb User Survey of Mobility (OPUS): Satisfaction with Device and Services
Time frame: 3-month follow-up
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).
Client Satisfaction Inventory-short form
Time frame: 3-month follow-up
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.
Prosthetic service utilization
Time frame: through study completion, an average of 3 months
Number of patient care minutes extracted from each participant's electronic medical record
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 41760154Sions JM, Stauffer SJ, Horne JR, Pohlig RT. Prosthetist screening for comorbidity during routine care visits: a randomised controlled clinical trial evaluating benefits, acceptability and feasibility. BMJ Open. 2026 Feb 27;16(2):e108623. doi: 10.1136/bmjopen-2025-108623.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn M Sions, PhD, DPT principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard-of-Care and Clinical Screening in people with Limb Ischemia and Low Back Pain, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthotic and Prosthetic Limb User Survey of Mobility (OPUS): Satisfaction with Device and Services (time frame: 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.