WithdrawnNot Applicable

Quality of Life in Amputated Patients Based on Social Deprivation Factors

Stopped: Staffing constraints

United States0Started 2024-02-26

Plain-language summary

The purpose of this study is to investigate the quality of life in patients who previously underwent major amputation, and to determine any correlation with social deprivation factors. We hypothesize that patients with increased social deprivation (public or no insurance, lower education, lower income, etc.) will have lower quality of life following amputation.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients who underwent major amputation via orthopaedic oncology attending at UF (transtibial, transfemoral, hip disarticulation, transhumeral, or trans-forearm) * Must be at least 6 months post amputation at the time of survey administration * Patients undergoing amputation for sarcoma, trauma, or chronic infection Exclusion Criteria: * Pediatric patients (\<18 years of age) * Adult patients with the following amputations: ray resection, transmetacarpal, wrist disarticulation, any other amputation distal to the carpi, Syme (ankle disarticulation), Chopart amputation, transmetatarsal, any other amputation distal to the tibia * Patients undergoing amputations for diabetes or vascular disease * Patients within 6 months post-operatively from their amputation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SF-36 Questionnaire

Timeframe: One visit at least 6 months removed from the amputation

MSTS Tumor Score Questionnaire

Timeframe: One visit at least 6 months removed from the amputation

Prosthesis Evaluation Questionnaire-Mobility Section (PEQ-MS)

Timeframe: One visit at least 6 months removed from the amputation

Trial details

NCT IDNCT06205745

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Amputations for Management of Sarcoma,Trauma,or Chronic Infection trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

SF-36 Questionnaire

Timeframe: One visit at least 6 months removed from the amputation

MSTS Tumor Score Questionnaire

Timeframe: One visit at least 6 months removed from the amputation

Prosthesis Evaluation Questionnaire-Mobility Section (PEQ-MS)

Timeframe: One visit at least 6 months removed from the amputation