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Evaluation the effects of N-acetyl Cysteine on diabetic foot ulcer

Phase 3
Conditions
Diabetic Foot Ulcer.
Diabetes mellitus due to underlying condition with foot ulcer
E08.621
Registration Number
IRCT20130917014693N17
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
100
Inclusion Criteria

Patients hospitalized in the infectious, internal and orthopedic departments of Loghman Hospital who have type 2 diabetes and unhealed diabetic foot ulcers
Patients with grade 3 according to the PEDIS criteria
Patients with osteomyelitis involvement proven by MRI or clinical criteria
Patients with ankle-brachial pressure index (ABI) between 0.9 and 1.3
Patients who have signed the consent form

Exclusion Criteria

Patients with a history of taking N-acetylcysteine, vitamin D and vitamin C in the last 2 weeks
Patients with a history of allergy to N-acetylcysteine ??or its derivatives
Patients with a history of asthma and bronchospasm
Pregnant and lactating patients
Patients taking immunosuppressive drugs
Patients who are discharged from the hospital within 1 week
Patients who have serum creatinine concentration above 2mg/d

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Area and depth of wound involvement. Timepoint: Duraing the study. Method of measurement: Sterile ruler.
Secondary Outcome Measures
NameTimeMethod
Inflammation factors including ESR (Erythrocyte sedimentation rate) and CRP (C-reactive protein). Timepoint: Every other day the beginning of the drug administration to the end of the study. Method of measurement: Laboratory.;White Blood Cell. Timepoint: Every other day the beginning of the drug administration to the end of the study. Method of measurement: Laboratory.;Edema. Timepoint: Once daily from the beginning of the drug administration to the end of the study. Method of measurement: Meter.
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