Status:
COMPLETED
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
Lead Sponsor:
Washington University School of Medicine
Conditions:
Diabetes Mellitus
Critical Limb Ischemia
Eligibility:
All Genders
30-90 years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
In this pilot clinical study the investigators propose to conduct a prospective, randomized, double-blinded, placebo-controlled clinical trial, in 50 participants with CLI who have undergone a major (...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03253328
Start Date
March 1 2017
End Date
June 27 2022
Last Update
August 16 2024
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110