Effects of N-acetylcysteine on Diabetic Foot Oxygenation

University of Turin

Status and phase: Completed; Phase 3

Conditions: Foot Ulcer, Diabetic

Treatments: Drug: N-acetylcysteine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01082445

NACPIEDE

Details and patient eligibility

About

The purpose of this study is to determine whether N-acetylcysteine is effective in the treatment or prevention of the foot ulcers in diabetic patients.

Enrollment: 100 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 45 and 70 years.
• Type 1 or 2 diabetes mellitus with foot ulcer (grade 0 stage C according to Texas University Classification).
• Written informed consent.

Exclusion criteria

• N-acetylcysteine assumption in the 6 months previous to the study.
• Hypersensibility to acetylcysteine.
• Neoplasms, severe systemic, hepatic, pulmonary, cardiovascular or renal diseases.
• Psychiatric diseases or drug abuse problems.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

50 patients that receive 600 mg of acetylcysteine for 3 times a day.

Treatment:

Drug: N-acetylcysteine

Placebo

Placebo Comparator group

Description:

50 subjects taking placebo pills 3 times a day

Treatment:

Drug: Placebo