Thermoregulation in Individuals With a Leg Amputation (NCT06458426) | Clinical Trial Compass
By InvitationNot Applicable
Thermoregulation in Individuals With a Leg Amputation
United States60 participantsStarted 2024-05-07
Plain-language summary
The goal of this project is to understand the factors that affect skin temperature (e.g., tissue above amputation site, and opposite foot) in people with amputation and diabetes. This project will also test the effects of 'shock-absorbing' prosthesis on skin temperature responses.
Who can participate
Age range
19 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:
* Individuals with a unilateral transtibial amputation, divided into two groups (with and without diabetes)
* Participants must classify as Medicare class K2 or higher (who can traverse low-level environmental barriers such as curbs, stairs or uneven surfaces).
* Participants must have undergone amputation at least 6 months prior.
* They must have the ability to walk for at least 10 continuous minutes without undue fatigue.
Exclusion Criteria:
* Neurological impairment that may affect walking function, such as stroke, severe traumatic brain injury, Parkinson's disease, and multiple sclerosis.
* History of inflammatory diseases, such as Raynaud's syndrome or rheumatoid arthritis.
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
1
Walking mechanics
Timeframe: during the intervention/procedure/surgery
2
Vascular physiology - macrocirculation
Timeframe: during the intervention/procedure/surgery
3
Vascular physiology - microcirculation
Timeframe: during the intervention/procedure/surgery
4
Temperature in lower limb
Timeframe: during the intervention/procedure/surgery
5
Comfort
Timeframe: during the intervention/procedure/surgery