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Low-Carbohydrate Diet for Amputation (PARADE Trial)
PARADE Trial Summary
This trial will help to assess the feasibility and efficacy of a low-carbohydrate diet to reduce pain and improve quality of life in amputees.
- Amputation
- Phantom Limb Pain
- Residual Limb Pain
PARADE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPARADE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PARADE Trial Design
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Who is running the clinical trial?
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- You had a limb amputated within the past 6 months.
- Group 1: Phase 2 Intervention
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this study open to individuals aged 55 and beyond?
"The prerequisites for enrolment in this research project require that the participant must be of legal age and not exceed 65 years."
Does my profile match the parameters necessary to join this clinical trial?
"This clinical trial is enrolling 50 individuals aged 18-65 who had an amputation at least 6 months ago and have passed Phase 1."
What endpoints are being sought by this clinical experiment?
"The primary outcome of this clinical trial will be ascertained at Baseline (week 0) and immediately after the intervention (week 6): a change in BPI Pain Interference. Additionally, secondary goals are assessing changes in the PROMIS-57 domain score, PSQI Change Score and CES-D score - all evaluated against their respective standardized benchmarks for comparison across time (Phase 2 only)."
Is this research program still open for participation?
"According to the information on clinicaltrials.gov, this research is presently recruiting volunteers. The medical trial was initially posted on July 1st 2022 and recently updated on July 13th 2022."
How many participants are actively taking part in this research?
"Correct. The records found on clinicaltrials.gov demonstrate that recruitment for this study, which was first published on July 1st 2022, is still going strong. 50 individuals must be drawn from a single medical facility in order to meet the requirements of the trial."
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