At a glance
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N-Acetyl-Cysteine for Healing of Amputation Stumps in the Setting of Diabetes
In Brief
A Early Phase 1 clinical trial evaluating Active Arm N-acetyl cysteine (NAC) and Placebo Arm for Diabetes Mellitus and 3 related conditions. Completed, enrolled 33 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
N-acetyl cysteine (NAC) 1200mg twice a day for 6 days post-amputation
Placebo 1/2 normal saline infusion twice a day for 6 days post-amputation