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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: Completed Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT03253328 is a Early Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 33 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Images were collected from the SPY Elite LAFA apparatus. Regions of interest were drawn in a standardized fashion around either the incision or the whole amputation stump. NIH image J software was used to evaluate peak perfusion signal intensity in all regions of interest. Change in LAFA was assessed at postoperative day (POD) 0, 3, and 5. Fold change in % perfusion in the ROI's between POD 0/3/5 was determined and compared between study groups. The primary outcomes were change in postoperative
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 |
What the finished NCT03253328 record still lists
NCT03253328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 2 interventions - of which Active Arm N-acetyl cysteine (NAC) is the first listed.
NCT03253328 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03253328's enrollment target sits among peer trials
33 763rd of 2000 higher than 1,227 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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
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