N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes (NCT03253328) | Clinical Trial Compass
CompletedEarly Phase 1
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
United States33 participantsStarted 2017-03-01
Plain-language 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.
Who can participate
Age range
30 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject undergoing elective major (above-knee or below-knee) lower extremity amputation for CLI
* Both male and female patients
* All ethnic groups
* Between of the ages of 30-90 years old
* Adequate nutritional status - defined as BMI \> 19
Exclusion Criteria:
* Pregnant women, and women who are breastfeeding
* Known history of end-stage liver disease
* Severe asthma
* Heavy alcohol consumption (male \> 2 drinks per day and women \> 1 drink per day)
* Individuals actively receiving chemotherapy.
* Anticipated enrollment in another study that investigates another drug agent within 30 days from enrollment in this study.
* Patients receiving carbamazepine.
* Severe anemia (HCT \< 22).
* Allergy to either NAC or Indocyanine Green (ICG).
* Patients with open wound(s) from a prior amputation on the ipsilateral limb (excluding patients who had prior partial foot amputation, who are now requiring a below-knee or above-knee amputation).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Postoperative Laser-Assisted Fluorescent Angiography (LAFA) Perfusion.
Timeframe: Day 0, Day 3, Day 5
2
Stump Healing Assessment at Postoperative Day (POD) 30.