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

NCT03253328 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-08-16

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Mohamed Zayed, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2021-08-31
Completion
2022-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253328 on ClinicalTrials.gov