Early Phase 1
Completed N=33
N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
Diabetes · Critical Limb Ischemia · Lower Limb Amputation Knee · Peripheral arterial disease
Source: ClinicalTrials.gov NCT03253328 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Change in Postoperative Laser-Assisted Fluorescent Angiography (LAFA) Perfusion. — 0.060; 0.096; 0.045; 0.031 percentage of defect
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Postoperative Laser-Assisted Fluorescent Angiography (LAFA) Perfusion. |
0.060; 0.096; 0.045; 0.031; 0.015; 0.050 | — |
| PRIMARY Stump Healing Assessment at Postoperative Day (POD) 30. |
10; 16; 7; 13; 3; 3 | — |
| SECONDARY Amputation Stump Perfusion in High Risk Patients |
7; 13; 3; 3 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03253328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.