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Effects of Trehalose on Peri-Trochanteric Fractures

Determining the Effects of Trehalose Consumption on Inflammation and Wound Healing in Patients with Peri-Trochanteric Fractures

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180404039188N5
Enrollment
64
Registered
2024-07-07
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Peri-trochanteric fractures. Pertrochanteric fracture

Interventions

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Admission to the orthopedic department of Talaghani Hospital with a diagnosis of pertrochanteric fractures. Age between 18 and 60 years. Injury Severity Score (ISS) less than 15. Willingness to cooperate and sign an informed consent form after full awareness of the study objectives and methods by the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: Pregnancy and lactation. Septic patients with unstable hemodynamics and metabolism. History of autoimmune diseases or disorders. History of cancer. Chemotherapy and radiotherapy within the past month. Diabetes mellitus Any type of liver failure Human immunodeficiency virus (HIV) infection. Morbid obesity (BMI > 40) Unwillingness to participate in the study Significant change in the patient's treatment process or admission to the ICU Intolerance to trehalose Patient being NPO and unable to start oral feeding Development of infection during the recovery and improvement period Alcohol consumption Smoking Different and heavy physical activity programs Those who are on a specific diet throughout the study Weight changes (±3) during the study Have a history of taking antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs) during the last month

Design outcomes

Primary

MeasureTime frame
Quality of wound healing. Timepoint: At the beginning of the study, measurements are taken on the second day, in week 2 and week 4. Method of measurement: Wound healing index.;IL-6. Timepoint: At the beginning of the study, week 4 and week 12 measurements will be taken. Method of measurement: Measurement of serum levels of IL-6.

Secondary

MeasureTime frame
ESR. Timepoint: at the beginning of study, week 4, week 12. Method of measurement: Measurement of serum levels of ESR.;CRP. Timepoint: at the beginning of the study, week 4, week 12. Method of measurement: Measurement of serum levels of CRP.;TNF-a. Timepoint: at the beginning of the study, week 4, week 12. Method of measurement: Measurement of serum levels of TNF-a.;CBC. Timepoint: at the beginnig of the study, week 4, week 12. Method of measurement: Blood test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Zandi

Shahid Beheshti University of Medical Sciences

Reza.zandi@sbmu.ac.ir+98 21 2243 2560

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026