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

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The Washington University

Status and phase

Completed
Early Phase 1

Conditions

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

Treatments

Drug: Active Arm N-acetyl cysteine (NAC)
Drug: Placebo Arm

Study type

Interventional

Funder types

Other

Identifiers

NCT03253328
201611065

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

30 to 90 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

33 participants in 2 patient groups, including a placebo group

Active Arm N-acetyl cysteine (NAC)
Active Comparator group
Description:
Upon study enrollment, patients will be randomized 1:1 by Investigational Pharmacy to a standard adult intravenous dose of NAC (1200mg twice a day) for 6 days post-amputation.
Treatment:
Drug: Active Arm N-acetyl cysteine (NAC)
Placebo Arm
Placebo Comparator group
Description:
Upon study enrollment, patients will be randomized 1:1 by Investigational Pharmacy to placebo ½ normal saline infusion (twice a day) for 6 days post-amputation.
Treatment:
Drug: Placebo Arm

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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