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Completed

NCT Number: NCT05410548

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 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.

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Key information

Conditions

Limb Ischemia Amputation Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Back Pain Behavior Behavioral Symptoms Cardiovascular Diseases Depression Low Back Pain Nervous System Diseases Neuritis Neurologic Manifestations Neuromuscular Diseases Neuropathy;Peripheral Pain Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Nervous System Diseases Peripheral Vascular Diseases Personal Satisfaction Psychological Well-Being Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware STAR Campus

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Standard-of-care

Other

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 Screening

Other

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.

Primary outcomes

  1. 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).

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • Independence Prosthetics-Orthotics, Inc.
  • Orthotic and Prosthetic Education and Research Foundation (OPERF)

Registry information

Official study title

Can Comorbidity Screening and Referral by Prosthetists Enhance Post-Amputation Care?

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2022
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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