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NCT03253328 · ClinicalTrials.gov registry record · Early Phase 1
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 33
- Enrollment target
NCT03253328 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 33 participants.
The verdict
NCT03253328, a Early Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major (above-knee or below-knee) lower extremity amputation. By exploring the primary endpoints we aim to determine whether NAC can affect amputation stump perfusion and healing. Based on preclinical data, the investigators hypothesize that NAC will augment both amputation stump perfusion as well as healing. The investigators will utilize the data from this trial to determine the true effect size that is necessary for a larger clinical trial to determine the clinical efficacy of NAC is healing surgical sites such as major lower extremity amputation stumps.
Interventions
- DRUG Active Arm N-acetyl cysteine (NAC)
- DRUG Placebo Arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2022-06-27 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03253328
The ClinicalTrials.gov registry entry for NCT03253328 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active Arm N-acetyl cysteine (NAC) is the first listed.
NCT03253328 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03253328 about?
NCT03253328 is a clinical study titled "N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes". In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial for 30 days for participants with critical limb ischemia (CLI) who undergo a major (above-knee or below-knee) lower extremity amputation. By exploring the pr...
What is the current status of trial NCT03253328?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 33 participants. The study started on 2017-03-01. Estimated completion is 2022-06-27.
What interventions are being tested in trial NCT03253328?
The interventions under investigation include: Active Arm N-acetyl cysteine (NAC) (DRUG), Placebo Arm (DRUG).
Who is sponsoring clinical trial NCT03253328?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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