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NCT00038285 · ClinicalTrials.gov registry record · Phase 2

Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)

A Phase 2 study of Vascular Disease, sponsored by US Department of Veterans Affairs.

Completed
Registry status
Phase 2
Development phase
1
Study location

NCT00038285 is a Phase 2 study of Vascular Disease that has completed, run by US Department of Veterans Affairs. The trial reports 1 study location across 1 state.

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The verdict

NCT00038285, a Phase 2 study of Vascular Disease, has completed, sponsored by US Department of Veterans Affairs.

COMPLETED
Registry status
Phase 2
Development phase
1
Study location

Study Summary

In the VA, we are achieving progress in decreasing amputation rates through early identification and multidisciplinary treatment of patients at risk for limb loss. Despite these accomplishments, however, clinical outcomes post-amputation, especially for PVD patients, have changed little because of patients' poor cardiovascular condition complicated by the injurious consequences of imposed inactivity begun in the preoperative period and continuing through convalescence. If not aggressively managed throughout all phases of recovery, these problems quickly render patients, already at risk, incapable of the rigors of rehabilitation as well as lead to reamputation, rehabilitation failure, and secondary complications. In our research, we are trying to transform this clinical scenario by applying what has succeeded in cardiac rehabilitation to services provided to amputees. In a series of studies, we are studying how to incorporate secondary CV risk factor modification and aggressive exercise interventions into conventional amputation rehabilitation through a program that we have named Healthy Heart Amputation Rehabilitation Therapy (Healthy H.A.R.T.). Our goal is to better: 1) increase aerobic capacity and promote rehabilitation achievements and quality of life, and 2) prevent postoperative complications and curtail further peripheral vascular deterioration through interventions found successful in cardiac rehabilitation. The basic assumption of this study will be that cardiovascular status and, thus, aerobic capacity is a most critical factor for rehabilitation success.

Conditions Studied

Interventions

  • PROCEDURE Amputation Prevention

Study Locations (1)

Texas

  • VA Medical Center - Houston

Trial Details

FieldValue
Start Date 2002-04
Est. Completion 2005-03
Phase Phase 2

Sponsor

US Department of Veterans Affairs

632 total trials

What the Registry Record Tells You About NCT00038285

The ClinicalTrials.gov registry entry for NCT00038285 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Vascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Amputation Prevention is the first listed.

NCT00038285 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00038285 about?

NCT00038285 is a clinical study titled "Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)". In the VA, we are achieving progress in decreasing amputation rates through early identification and multidisciplinary treatment of patients at risk for limb loss. Despite these accomplishments, however, clinical outcomes post-amputation, especially for PVD patients, have changed little because of p...

What is the current status of trial NCT00038285?

This trial is currently completed. It is a Phase 2 study. The study started on 2002-04. Estimated completion is 2005-03.

What conditions does trial NCT00038285 study?

This clinical trial studies the following conditions: Vascular Disease.

What interventions are being tested in trial NCT00038285?

The interventions under investigation include: Amputation Prevention (PROCEDURE).

Who is sponsoring clinical trial NCT00038285?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00038285 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.