NCT03253328

N-Acetyl-Cysteine (NAC) for Healing of Amputation Stumps in the Setting of Diabetes

N-Acetyl-Cysteine for Healing of Amputation Stumps in the Setting of Diabetes

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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 (above-knee or below-knee) lower extremity amputation. 25 participants will receive NAC 1200mg intravenously twice a day for 6 consecutive days following amputation. 25 participants will receive placebo saline intravenous infusion twice a day for 6 days following amputation. Post-amputation participants will be monitored for specific anthropometric parameters and stump perfusion assessments (using laser-assisted fluorescent angiography and transcutaneous oxygen pressure measurement). The primary study endpoints are to determine if lower extremity stump healing and perfusion are affected by perioperative NAC administration. A secondary endpoint will be to determine the effect size that would be necessary to power a larger clinical trial to determine whether NAC treatment can affect tissue perfusion and healing at major lower extremity amputation stumps in participants with CLI.

Conditions

• Diabetes Mellitus
• Critical Limb Ischemia
• Lower Limb Amputation Knee
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Active Arm N-acetyl cysteine (NAC)	N-acetyl cysteine (NAC) 1200mg twice a day for 6 days post-amputation
DRUG	Placebo Arm	Placebo 1/2 normal saline infusion twice a day for 6 days post-amputation

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-08-31
• Completion: 2022-06-27
• First posted: 2017-08-17
• Last updated: 2024-08-16
• Results posted: 2024-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study