Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00447655 · ClinicalTrials.gov registry record · Phase 1
Improving Outcomes Following Limb Loss: PALS Plus
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 400
- Enrollment target
NCT00447655: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT00447655 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 400 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (567% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00447655, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 400 participants
- Enrollment target
Study Summary
Limb loss can result from a variety of etiologies including diabetes, trauma and cancer. Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life. Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss. Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training. Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus. The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss. A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group. Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group. Assessment will be at baseline, treatment completion and six month follow-up. Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood. Secondary outcome measures are: function, participation and bothersomeness of limitations. The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss. Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabil
Interventions
- BEHAVIORAL Self-management and peer support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2007-03 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00447655 record still lists
NCT00447655 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (567% higher).
The record links to 0 conditions, and to 1 intervention - of which Self-management and peer support is the first listed.
NCT00447655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00447655 about?
NCT00447655 is a clinical study titled "Improving Outcomes Following Limb Loss: PALS Plus". Limb loss can result from a variety of etiologies including diabetes, trauma and cancer. Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life. Intervention: Working with the Amputee Coaliti...
What is the current status of trial NCT00447655?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 400 participants. The study started on 2007-03. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00447655?
The interventions under investigation include: Self-management and peer support (BEHAVIORAL).
Who is sponsoring clinical trial NCT00447655?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00447655's enrollment target sits among peer trials
400 75th of 2000 higher than 1,924 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01665326 · 400 participants
Determination of CRIM Status and Longitudinal Follow-up of Individuals With Pompe Disease
- NCT02108054 · 400 participants · NA
Behavioral and Functional Task Development, Implementation, and Testing
- NCT02216500 · 400 participants · NA
Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
- NCT02250352 · 400 participants
Core Biopsies for Establishing a Breast Tumor Tissue Repository
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia