A Study Comparing Rigid Removable Dressing Systems for Improving Healing and Activity Levels Following Lower Leg Amputations
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-001707
Sponsor Protocol Number: 14-001707
About this study
The purpose of this study is to compare different rigid removable dressing systems that are used to heal and protect a limb following an amputation by measuring the healing of the surgical incision and the activity level of patients following surgery.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Cognitive ability to apply activity monitors and respond to surveys
- Acute unilateral trans-tibial amputation
- Received rigid removable dressing during their post-operative care
Exclusion Criteria
- Non-ambulatory prior to trans-tibial amputation
- Post-surgical restrictions or disabilities that would limit ambulation with gait aid, ie
- prolonged bedrest
- medications that reduce balance
- upper extremity weight bearing restrictions
- < age 21
- Pregnant
- Comorbidity (such as neurological disorder or rheumatoid arthritis) that would affect participant’s activity level
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Kenton Kaufman, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available