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Healthy Heart Amputation Rehabilitation Treatment (H.A.R.T)
NCT00038285 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Start Date | 2002-04 |
| Est. Completion | 2005-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00038285
The ClinicalTrials.gov registry entry for NCT00038285 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 158 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00038285 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00038285?
The interventions under investigation include: Amputation Prevention (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00038285?
This trial is sponsored by US Department of Veterans Affairs, which has 158 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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