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Evaluating the Effectiveness of Nitroglycerin in Treating Diabetic Wounds: A Double-Blind Randomized Clinical Trial

Evaluating the Effectiveness of Nitroglycerin in Treating Diabetic Wounds: A Double-Blind Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240623062229N2
Enrollment
50
Registered
2025-02-22
Start date
2025-02-28
Completion date
Unknown
Last updated
2025-07-21

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

Interventions

Intervention 1: Intervention group: Nitroglycerin spray (two puffs with a concentration of 0.4 grams) + standard treatment of diabetic foot ulcers based on Wegener classifications 2 and 3. In addition

Sponsors

Dezfoul University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Type 2 diabetes and a chronic (at least 6 weeks) full-thickness (above or below the malleolus) foot ulcer with a cross-sectional area of ??more than 25 mm2. Diabetic foot ulcer in one area of ??the foot and in one leg and below the ankle Hospital admission for wound management within 48 hours of starting standard treatment.

Exclusion criteria

Exclusion criteria: Patients who have started standard treatment for diabetic foot ulcers and 48 hours have passed. Patients with wounds other than diabetic foot ulcers, such as surgical wounds. Patients with immunodeficiency, or patients taking immunosuppressive drugs. Patients with diabetic ulcers with Wagner grade 0, 1, 4 and 5 and may be in the inpatient ward for any reason. Patients who are candidates for surgery. Patients who, after discharge from the hospital, continue their treatment at home or in other centers not associated with this plan. Patients who take alteplase, heparin, tricyclic antidepressants and other anticholinergic drugs. In such patients, if the doctor determines that the prescription of TNG is not contraindicated, it will be taken on a case-by-case basis. People who have consumed alcohol in the past 24 hours. Lactating mothers Pregnant women

Design outcomes

Primary

MeasureTime frame
Ulcer surface area. Timepoint: Before the study, then at weekly intervals until the end of the study. Method of measurement: Taking a picture of the wound at a certain distance and one meter away and then analyzing it with image analysis software such as ImageJ.;Wound healing duration. Timepoint: From the time of starting treatment until the wound closes, if not more than three months. Method of measurement: Time interval based on days.

Secondary

MeasureTime frame
Length of hospital stay due to wound. Timepoint: The interval between admission and discharge if the discharge is due to recovery and not other reasons, such as changing treatment centers. Method of measurement: Time interval based on days.;Biochemical and hematological parameters as baseline variables such as CBC, Na, K, HbA1c, fasting glucose and insulin. Timepoint: Before and after the intervention. Method of measurement: The concentration of the parameter in the blood: glucose, mg/dL; insulin, mmol/L; sodium and potassium, milliequivalents/L; CBC, cells by number per ml of blood and their percentage relative to each other.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Norouzirad

Dezfoul University of Medical Sciences

norouzirad@dums.ac.ir+98 61 4252 3857

Outcome results

None listed

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