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Behavioral Intervention

Low-Carbohydrate Diet for Amputation (PARADE Trial)

N/A
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Amputation at least 6 months prior Phase 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0), immediately after the intervention (week 6)
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Amputation
  • Phantom Limb Pain
  • Residual Limb Pain

PARADE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PARADE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0), immediately after the intervention (week 6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), immediately after the intervention (week 6) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BPI Pain Interference Change
BPI Pain Severity Change
SF-36 overall score change
Secondary outcome measures
AAQ change score
CES-D score change
CFS score change
+6 more
Other outcome measures
Weight change

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

PARADE Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 2 InterventionExperimental Treatment1 Intervention
Low-Carbohydrate Diet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low-Carbohydrate Diet
2022
N/A
~990

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,548 Previous Clinical Trials
2,287,703 Total Patients Enrolled

Media Library

Low-Carbohydrate Diet (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05460845 — N/A
Amputation Research Study Groups: Phase 2 Intervention
Amputation Clinical Trial 2023: Low-Carbohydrate Diet Highlights & Side Effects. Trial Name: NCT05460845 — N/A
Low-Carbohydrate Diet (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05460845 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~11 spots leftby Feb 2025