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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

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

Eligibility Criteria

Inclusion Criteria

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

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

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
1,599 Previous Clinical Trials
2,287,892 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
~9 spots leftby Jul 2025
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