Foot Injury Clinical Trial
Official title:
Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
Verified date | June 2019 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to determine if patients wearing a CAM walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information.
Status | Terminated |
Enrollment | 20 |
Est. completion date | May 23, 2019 |
Est. primary completion date | April 9, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age greater or equal to 18 (male or female) - Participants prescribed a CAM boot as standard of care from the study investigator's practice - Participant willing to have weight measured at the clinic site at time of enrollment and final visit - Participants willing to have blood drawn for Albumin level at beginning and end of study - Participant is able to provide voluntary, written informed consent - Participant, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits. - Fluent in written and spoken English Exclusion Criteria: - Participants less than 18 years of age - Pregnant women - Cognitive impairment - Participants with vertigo or other balance issues - Participants unable to provide informed consent - Non-English speaking individuals - Participants who will not be wearing a CAM boot for at least 6 weeks - Participants unable/unwilling to perform upper body exercises and follow nutrition guidelines |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Nell Blake, DPM |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight change | Determine weight gain or loss at time patient no longer is required to wear CAM boot, up to and including 12 weeks. | Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks | |
Secondary | Nutritional status (Pre- and post-albumin levels) | Pre- and post-albumin levels to measure protein and provide nutritional status | Enrollment through study completion, an average of 12 weeks. |
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