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

Evaluation the effects of N-acetyl Cysteine supplementation on wound healing and inflammation in patients with diabetic foot ulcer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20130917014693N17

Enrollment

100

Registered

2024-07-11

Start date

2024-09-22

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer. Diabetes mellitus due to underlying condition with foot ulcer

Interventions

Intervention 1: Intervention group: In addition to receiving the prescribed treatments, patients with diabetic foot ulcer will receive N-acetyl cysteine ??made by Hakim Pharmaceutical company (Acestin

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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/dL

Design outcomes

Primary

Measure	Time frame
Area and depth of wound involvement. Timepoint: Duraing the study. Method of measurement: Sterile ruler.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Sahraei

Shahid Beheshti University of Medical Sciences

z.sahraei@sbmu.ac.ir+98 21 8820 0118

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026