N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes
Status:
Suspended
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.